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Compromised Skin Grafts and Flaps

Compromised Skin Grafts and Flaps

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Compromised Skin Grafts and Flaps

INTRODUCTION

Treatment Protocol Guidelines

The following hyperbaric medicine treatment protocol is based upon the recommendations of the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric Medical Society. Clinical protocols and/or practice guidelines are systematically developed statements that help physicians, other practitioners, case managers and clients make decisions about appropriate health care for specific clinical circumstances.  

Protocols allow health providers to offer evidence-based, appropriate, standardized diagnostic treatment and care services to patients undergoing hyperbaric oxygen therapy (HBOT).  Evidenced-based medicine offers clinicians a way to achieve improved quality, improved patient satisfaction, and reduced costs. Utilization Review should be initiated when clinical decisions result in deviation from or modification of treatment protocols.  This includes any course of treatment at or above the recognized threshold limits. 

Medical Necessity

Medicare.gov defines “medically necessary” as “health-care services or supplies needed to prevent, diagnose, or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.” 

This topic discusses Compromised Skin Flaps and Grafts, including reimplantation of digits or extremities.  This condition meets coverage indications per the National Coverage Determination (NCD) 20.29. [1] Continued HBOT without documented evidence of effectiveness does not meet the Medicare definition of medically necessary treatment. Thorough re-evaluation should be made at least every 30 days for documentation of response to therapy. 

TREATMENT PROTOCOL


 HBO request requirements checklist   |  Sample Physician Order   | $ ICD-10 Crosswalk   |  Treatment Table   Urgent Indication 

Background Hyperbaric oxygen therapy is not indicated to improve viability of routine, uncompromised skin grafts or flaps. However, in cases where there is decreased perfusion or frank hypoxia in the absence of surgically treatable mechanical causes of flap compromise, HBO can help maximize the viability of the compromised tissue, thus reducing the need for re-grafting or repeat flap procedures. 

Mutilated limb injuries often lead to limb loss and severe functional impairment. When combined with meticulous microsurgical revascularization or replantation, early intervention with adjunctive HBOT can improve the survival of mutilated hands and preserve hand function as much as possible.[2] 

Goals of HBOT

    Maximize tissue viability, aiming at complete or at least partial salvage of compromised flaps and grafts by:

    • Increasing tissue oxygen concentrations in sub-optimally perfused areas to limit cellular death and further tissue damage
    • Stimulating secretion of collagen by fibroblasts and enhancing neovascularization
    • Increasing tissue perfusion by reducing capillary leakage, tissue swelling and edema 
    • Improve survival of replanted part
    • Limit effects of ischemia and ischemia-reperfusion injury by [2]: 
      • elevating tissue oxygenation
      • stimulating leukocyte function
      • decreasing peripheral edema
      • reducing TNF-alpha and other triggers of the inflammatory cascade
    • Provide tissue oxygenation to replanted part while vascularization is established 
    • Facilitate neovascularization in replanted digits

    Diagnosis

    Compromised soft tissue flaps and grafts without correctable mechanical causes that may be obstructing blood flow to flap and with questionable viability may present with findings that include obvious ischemia, discoloration, venous congestion, decreased temperature and inadequate transcutaneous oxygen response.[3][4]  

    Traumatic amputated limbs/ digits (e.g., from crush, degloving, cutting, or explosion injuries), and surgically treated with replantation 

    Hyperbaric

    Criteria 


    • Surgical referral with diagnosis and documentation of skin graft or flap compromise (e.g., random pattern ischemia, pain, coolness or a bluish/purple hue of the cutaneous portion of flap)
    • Absence of surgically correctable cause of decreased perfusion to flap or skin graft (e.g. skin flaps created by trauma with inadequate perfusion due to crush injury, large random flaps that do not follow the classic 3:1 length-to-width ratio, ischemia-reperfusion injuries, etc)
    • Initiation of first HBO session within 24 hours of the initial limb/ digit replantation/ revascularization. This is generally considered a hyperbaric emergency and due consideration for urgent (within one to a few hours) initial treatment in a hyperbaric chamber. 
    • Postoperative edema and congestion, in the absence of obvious surgically correctable causes of ischemia or congestion 
    • Postoperative concerns regarding viability of the replanted part. A reference to a verbal conversation with the surgeon is adequate documentation. 

    Evaluation

    • Comprehensive history
    • Physical examination
    • Complete Blood Count (CBC)
    • Erythrocyte Sedimentation rate (ESR)
    • C-reactive protein (CRP)
    • Chest x-ray
    • Electrocardiogram (ECG)
    • Transcutaneous oxygen (TCOM) assessment or doppler studies (If they can be performed without delaying initial therapy). While TcPO2 values are helpful, they should never be required as a barrier to treating these patients. 
    • Wound assessment documentation and immediate photography (if the wound/site is accessible without removing dressings)
    • Evaluation of tympanic membranes pre- and post-treatment as needed
    • Baseline and as needed visual acuity assessment for progressive myopia
    • Smoking/nicotine cessation
    • Nutritional assessment; dietary management;
    • Blood glucose control

    Treatment

    • Hyperbaric oxygen therapy at 2.0-2.5 ATA oxygen for 90 minutes. (Table 1 or Table 3)
    • Hyperbaric Oxygen therapy should be started as soon as signs of flap or graft compromise appear.
    • In an acutely failing flap, up to 3 treatments in the first 24 hours is recommended.
    • After the first 24 hours, twice daily treatments are recommended. This may continue until the hyperbaric physician and the surgeon agree that the flap is stable clinically or the flap shows signs of progress toward healing.
    • If the flap or graft begins to show evidence of advancing ischemia, the aggressive twice daily treatment protocol can be continued.
    • Should the compromised graft or flap fail, daily HBO treatments may be continued to prepare the compromised wound bed for a salvage graft or flap reconstruction. 
    • Consider TCOM at the flap site to monitor tissue oxygenation.
    • Flap or graft dressing change as indicated only by the surgeon

    Follow-Up

    • Transcutaneous oxygen assessment and doppler studies, if the flap is accessible and stable
    • Visual acuity assessment for progressive myopia
    • Photographic documentation of wound/replanted part

    Treatment Threshold

    6 – 20 treatments (concurrent peer review after 10 and 20 treatments, third party peer review after 25) 

    Coding

    Refer to the ICD-10 Guideline for the appropriate ICD-10 code

    Comments

    • It is important to recognize the underlying cause of the compromise of the flap or graft. Any correctable mechanical cause of decreased flap perfusion should be considered with surgical re-exploration. 
    • All flaps by definition have an inherent blood supply whereas grafts are avascular tissues that rely on the quality of the recipient bed for survival and revascularization. Because of this dependence, the diagnosis of compromised graft begins with assessment of the recipient wound bed. A graft (whether partial- or full-thickness) is not an urgent indication. In fact, HBOT should not be considered until the grafted tissue is declared non-viable and has failed advanced wound care therapy.
    • If diabetes mellitus is present, blood glucose should be checked within 1 hour prior to treatment and immediately post-HBOT.
    • Avoid petroleum based dressings and ointments whenever possible. If these are a necessary covered with 100% cotton during HBOT.
    • HBOT cannot salvage flaps with capillary thrombosis due to insufficient venous outflow. However, HBOT may help distinguish replanted flaps with insufficient venous outflow that need anastomosis revision (or leech therapy) in the early postoperative phase. These flaps are congested with "venous blood" and their color may change to bright pink during HBOT session, as a result of conversion of hemoglobin into oxyhemoglobin in the presence of sufficient dissolved oxygen.[5]
    • This indication may not be covered by the patient's health insurance plan. Confirmation of criteria to meet medical necessity and potential pre-authorization is recommended prior to starting HBOT.
    Primary Sources: Whelan and Kindwall [6]Weaver [7], National Baromedical Services [8] 

    DOCUMENTATION

    Hyperbaric oxygen therapy has been shown to be beneficial in the treatment of acutely compromised soft tissue flaps. In the acute case tissue is rendered hypoxic resulting from the surgical disruption of the transplanted tissue’s arterial blood supply. In many cases, this disruption is planned in conjunction with a free flap procedure. In some cases, the tissue may be further compromised through an ischemia-reperfusion injury or a “flow no reflow” phenomenon. In this acute scenario, hyperbaric oxygen provides a means for adequate oxygen delivery to tissue at risk and allows for continued oxidative metabolism thereby limiting the loss of transplanted tissue. HBOT has also been shown to attenuate the ischemia-reperfusion injury through preventing or limiting the ensuing inflammatory response. In the setting of a previously failed flap or graft, HBOT can be leveraged to help prepare the wound bed for subsequent surgical repair through enhanced angiogenesis and granulation tissue formation. Questionable viability may include obvious ischemia, discoloration, venous congestion, decreased temperature, and inadequate transcutaneous oxygen response. Below we explain in detail what needs to be documented and provide sample statements that can be adapted to suit your needs. See also:

    •  HBO request requirements checklist

    History 

    An initial assessment including a history and physical that clearly substantiates the condition for which HBO is recommended. Items listed below should be included:

    • Prior medical, surgical procedures and/or HBO treatments 
    • Date flap or graft was performed, type of flap or graft and name of the surgeon
    • Clinical assessment of the flap or graft

    Sample documentation for an acutely failing flap is shown below:

    "Mrs. Jones was seen urgently, after-hours, at the request of Dr. Anglen (our breast plastic surgeon). Dr. Anglen had just performed a breast reconstruction with a latissimus dorsi free flap on the left side. By the time the patient reached recovery room, the flap was dusky and looked poorly perfused. The vascular assessment was undertaken with a Doppler probe and flow was positive at the arterial anastomosis. Some sutures were removed to help with venous congestion. Dr. Anglen is concerned about the overall viability of the free flap and has asked us to urgently consult for immediate HBOT in order to assist with viability and prevention of ischemia-reperfusion injuries."

    Sample documentation for a failed flap/graft where HBOT will be used for "preparation of a flap/graft" is shown below (NOTE: This indication varies by insurer/intermediary, so be sure that you have carefully looked at the NCD/LCD before you proceed.)

    "Mr. Jones had a distant pedicle flap raised from his forearm 10 days ago. The forearm was attached to his forehead in order to cover for a MOHS surgical wide excision to skull. The goal of the surgery was to start the flap with the forearm attached, then come back and complete the procedure by releasing the forearm after half of it had a chance to vascularize on the recipient area. On examination by our plastic surgeon, the flap has failed entirely, leaving a 10 x 20 cm failed deficit. We have chosen to leave the eschar in place in order to protect the skull underneath. The indication for HBOT is a failed forearm to forehead pedicle flap with preparation for a myocutaneous free flap in the future. It is important to note that the surrounding tissue has never been radiated."

    (NOTE: To address the failed distant pedicle flap described in this scenario, we would suggest at least 15 - 20 HBOT treatments, followed by surgical debridement of remaining non-viable tissue, and a free flap to cover the forehead defect. If the free flap looks at all questionable postoperatively, we suggest another 10 - 15 post-operative treatments based on flap appearance and viability. If the free flap fails, other options to cover this area of skull are limited)

    Physical Exam

    • Documentation of Failing or Failed Flap (one of the following must be present)
      • Mottling/random pattern ischemia
      • Suture line dehiscence, areas of eschar 
      • Partial loss of flap
      • Threatened complete loss of flap
    • Documentation of optimization of nutritional status 
      • Albumin
      • Pre-Albumin
      • If abnormal, have a dietary/nutritionist consult to apply measures that address deficiencies. Document in a clinical note that this has been done.
    • Documentation of optimization of glucose control
      • HgbA1-C level; the results may be obtained from the primary care physician.
      • Documentation of measures taken to address poorly controlled blood glucose
      • While glucose control is important, there are no randomized controlled trials that link healing rate to HbA1c levels [9] 
    • Documentation of debridement by any means to remove devitalized tissue
      • In some cases, just document that there is no devitalized tissue present
      • Plan for debridement (as required)
    • Documentation of necessary treatment to resolve any infection that might be present.
      • In some cases, simply document that the wound/ulcer is free of infection. Sample: "The wound was examined. There was no erythema, no purulence, and no evidence of infection seen."
      • Measures taken to address treating any existing infection present.

    Impression

    • Compromised graft or flap Refer to ICD-10 Crosswalk

    Plan

    "A typical hyperbaric regimen for a patient with a compromised flap or graft consists of twice daily 2.0 to 2.4 ATA hyperbaric oxygen treatments with 90 to 120 minutes of oxygen breathing time. The flap or graft is monitored serially and the aggressive twice daily treatment schedule is continued for at least 48 hours, then daily hyperbaric oxygen treatments will follow until the flap or graft shows signs of progress toward healing. If the flap or graft begins to show evidence of advancing ischemia, the aggressive twice-daily treatment protocol can be extended or renewed.

    Having no absolute contraindication to hyperbaric oxygen therapy the patient will be offered treatment at 2.0 ATA for 90 minutes. Ten treatments will initially be provided on a BID basis. Thereafter, a re-evaluation of the patient’s clinical progress will be in order to determine if additional treatments may be required."copy enabled

    Risk and Benefit of Hyperbaric Oxygen Therapy

    Please refer to topic "Documentation HBO: Risks and Benefits"

    Indication for Hyperbaric Oxygen Therapy (HBOT)

    "Hyperbaric oxygen therapy is not needed for routine, uncompromised skin grafts or flaps. However, in cases where there is decreased perfusion or frank hypoxia, hyperbaric oxygen can help maximize the viability of the compromised tissue thus reducing the need for re-grafting or repeat flap procedures. There are multiple clinical studies showing the benefit of hyperbaric oxygen for failed or failing flaps and skin grafts. Types of grafts and flaps studied include free skin grafts, pedicle flaps, random flaps, irradiated wounds and flaps, composite grafts and axial pattern flaps. Although the types of flaps and grafts are different, the common denominator to flap necrosis is tissue hypoxia. 

    Hyperbaric oxygen can be beneficial in managing failing flaps and skin grafts by several mechanisms: 1) Increasing tissue oxygen concentrations over 1000%, thus preventing cellular death, 2) stimulating fibroblasts and macrophages to secrete collagen and enhance neovascularization, 3) reducing edema formation by reducing capillary leakage and tissue swelling, thus increasing tissue perfusion, and 4) maintaining the bacterial killing ability of leukocytes after phagocytosis."

    Sample Order

    •  Sample Physician Order

    Documentation by Certified Hyperbaric Nurse and Certified Hyperbaric Technician 

    The certified hyperbaric technician (CHT) and certified hyperbaric nurse (CHRN) should maintain an accurate record of the care and related support services delivered during each patient’s course of hyperbaric oxygen therapy. The patient's chart is a legal document and as such, must reflect in meaningful terms the patient's condition, progress, and care rendered. The provider and nurse's notes must be concise, accurate, and support medical necessity for the treatment ordered. The notes must reflect responsibility for the care rendered. For details, see topic "Documentation: Hyperbaric Treatment Notes by the CHRN and CHT"

    Daily treatment should include, but is not limited to the following: 

    • Physician Order - confirm daily HBO treatment order.
    • Patient Assessment (by the CHRN or CHT) 
    • Pre-treatment Safety Check (by the CHRN or CHT)
    • Documentation of the Treatment Log (by the CHRN or CHT)
    • Physician Supervision (by the CHRN or CHT)
    • Care Provided (by the CHRN or CHT)
    • Plan of Care (by the CHRN or CHT, based on physician orders)

    CLINICAL EVIDENCE AND RECOMMENDATIONS  

    • 2CFor patients with compromised skin flaps or grafts, we suggest HBOT to salvage and increase survival rates of skin flap or graft (Grade 2C)
      • Rationale: Currently, low certainty evidence supports the use of HBOT to salvage compromised flaps and grafts (evidence level C), with evidence primarily drawn from animal, observational studies and many case series.[3][10][11][12][13][14]There have been no randomized controlled trials (RCTs) that addressed the use of HBOT to salvage compromised flaps and grafts to date. Only 1 RCT [15] studied HBOT on the survival of skin grafts, however all patients with skin grafts (not only compromised skin grafts) were included, and the RCT was considered at high risk of bias due to lack of patient blinding, incomplete outcome data, and selective reporting [16].
      • In practice, HBOT has been shown to be beneficial in the treatment of acutely compromised soft tissue flaps. In the acute setting, the tissue is rendered hypoxic resulting from the surgical disruption of the transplanted tissue’s arterial flow. In some cases,  tissue may be further compromised through an ischemia-reperfusion injury or a “flow no reflow” phenomenon. In this acute scenario, hyperbaric oxygen provides a means for adequate oxygen delivery to tissue at risk and allows for continued oxidative metabolism thereby limiting the loss of transplanted tissue. HBOT has also been shown to attenuate the ischemia-reperfusion injury through preventing or limiting the ensuing inflammatory response. [4] Mechanisms of action by which HBOT is beneficial for compromised flaps are listed below:
        • Reversal of tissue hypoxia
        • Reducing localized edema surrounding the flap
        • Reduction of hypoxic insult
        • Provides immediate support of marginally perfused/oxygenated portions of the flap
        • Enhancement of fibroblast and collagen synthesis
        • Creation of neovascularity
        • Possibly closes arteriovenous shunts
        • Favorable effects on micro-circulation by reducing TNF-alpha and Matrix Metalloproteases. HBOT improves Nitric Oxide and oxidative pathways.
      • To be maximally effective, HBOT should be started as soon as signs of flap or graft compromise appear. [4] Mechanical causes of flap compromise that can be treated surgically should be addressed prior to initiation of HBOT. In the setting of a previously failed flap or graft, HBOT can be leveraged to help prepare the wound for subsequent surgical repair through enhanced angiogenesis and granulation tissue formation. The criteria for selecting the proper patients who are likely to benefit from adjunctive HBOT for graft or flap compromise are crucial for a successful outcome. Identification of the underlying cause for graft or flap compromise can assist in determining the proper clinical management and use of HBOT. [4] Questionable viability may include obvious ischemia, discoloration, venous congestion, decreased temperature and inadequate transcutaneous oxygen response. [3][4]  
      • Use of resources: Failed flaps are extremely expensive and result in significant morbidity and distress to both the patient and the surgeon. Adjunctive HBOT can reduce these financial, physical and psychological costs by salvaging skin grafts, pedicle flaps, random flaps, composite grafts, as well as free flaps and thus eliminating or minimizing the need for secondary surgeries and alternate donor sites. [4] 
      • Medicare Coverage: Medicare covers HBOT when it is utilized for graft or flap salvage in cases where hypoxia or decreased perfusion has compromised the viability of an existing skin graft or flap. Medicare coverage does not apply to the initial preparation of the body site for a graft. [1] See  HBO Request Requirements Checklist, and section on 'Coverage and Reimbursement' below.

      "A typical hyperbaric regimen for a patient with a compromised flap or graft consists of twice daily 2.0 to 2.4 ATA hyperbaric oxygen treatments with 90 to 120 minutes of oxygen breathing time. The flap or graft is monitored serially and the aggressive twice daily treatment schedule is continued for at least 48 hours, then daily hyperbaric oxygen treatments will follow until the flap or graft shows signs of progress toward healing. If the flap or graft begins to show evidence of advancing ischemia, the aggressive twice-daily treatment protocol can be extended or renewed.

      OPERATIONAL CONSIDERATIONS

      Providing HBOT in a safe manner is the primary objective with each and every treatment. The clinical team (physician, CHT, CHRN, etc) providing HBOT goes to great lengths to ensure patient safety with every treatment. A summary of operational considerations pertaining to adjunct HBOT for compromised skin grafts and flaps is provided below:

      Chamber Inspections

      • Routine chamber inspections should be conducted to confirm chamber maintenance procedures and the safe operation of all equipment utilized during HBO therapy.
        • To ensure the safety of the environment in the hyperbaric medicine facility, chamber inspections are to be performed routinely (i.e. daily, monthly, semi-annually, as needed). Processes and systems that meet standards set forth by The Joint Commission (TJC) and the Undersea and Hyperbaric Medical Society (UHMS) should be utilized, and elements that have been developed within the field (in some cases through “near misses”) may be incorporated. These processes and systems can be implemented through customized patient-centered checklists. Checklists have a wide range of applications, with the potential to improve patient education, pre-procedure planning, discharge instructions, care coordination, chronic care management, and plans for staying well. 
        • For resources on chamber inspections, see topic "HBO Safety Inspections".

      Ground testing 

      • NFPA 99 requires that all hyperbaric chambers are grounded and patients inside chambers filled with 100% oxygen are likewise grounded. Wrist continuity tests prior to each treatment and daily chamber checks including chamber stud to wall measurements and patient ground jack to chamber stud measurements ensure ongoing continuity. 

      Prohibited Item(s), Assessment and Authorization 

      • Wound dressings, devices, and other objects that go in the hyperbaric chamber with the patient may raise important safety concerns, including the production of heat, production of static electricity, production of flammable vapor, ignition temperature, and total fuel load. It is critical that clinicians understand which dressings, devices, and objects are prohibited, restricted or allowed inside a hyperbaric chamber during HBOT for compromised skin grafts and flaps. 
      • Frequently, questions arise in regard to what can be taken into the chamber. The NFPA 99 2012 edition, chapter 14 "Hyperbaric Facilities", provides the process for effectively managing patient care product(s) during HBOT.  The NFPA 99 2018 edition - 14.3.1.6.4.4 states “Physician and Safety Director approval to use prohibited items shall be stated in writing for all prohibited materials employed”. [17]
        • Each hyperbaric facility should maintain an internal list of items that are approved for use, should be used with caution and should not be used in the chamber. An authorization form is required for items that should be used with caution. To facilitate assessment, clinicians might opt to utilize the Go-No-Go Risk Assessment Tool. The tool is an interactive process that enables hyperbaric technicians, Safety and Medical Directors to document the product information necessary to complete the risk assessment process. Upon completion of the process, the user will have the ability to print or email the document. In addition, clinicians can review lists of items that are approved for use, should be used with caution and should not be used in the chamber. See " Go-No-Go Lists / Prohibited Items" and "Go-No-Go : Frequently  Asked Questions". 

      Ancillary Equipment

      • All equipment utilized by the hyperbaric medicine facility is maintained through a program of regular preventative maintenance. The manufacturer maintains the hyperbaric chambers during the regularly scheduled service contract. Ancillary equipment (e.g. cardiac monitor leads, TCOM sensors) should be serviced by the Hospital's Biomedical Department and maintained in accordance with the recommendations of the manufacturer.  See topics "Ear Exam - Barotrauma" and "Ancillary Equipment"      

      Air Breaks 

      • During HBOT for compromised skin grafts and flaps, it is necessary to provide an alternative air breathing source. This may also be necessary to reduce the risk of central nervous system oxygen toxicity.  The air breathing system consists of an independent high-pressure air source, capable of providing flow that is sufficient to meet the patient's inspiratory demand. Air breathing systems may be provided by institutional gas outlet (wall outlet) or via portable "H" cylinders utilizing a diameter index safety system (DISS) regulator.  Delivery of the air break to the patient may be provided by disposable non-rebreather mask, demand valve and resuscitation mask or trach collar.  For purposes of infection control, masks should be single patient use and cleaned or replaced (per patient) as needed.
      • While the use of air breaks to decrease the incidence of CNS oxygen toxicity has not been directly demonstrated, there is a large amount of published data on the cause of oxygen toxicity related directly to a combination of the level of FiO2 and time. As such, these air breaks limit the interval time exposure and are expected to decrease the risk of oxygen toxicity.[18]  

      Infection Control - Cleaning/ Disinfection of the Hyperbaric Chamber 

      • The cleaning and disinfection of acrylic monoplace chambers is done with caution because many commercial biohazard-cleaning agents contain alcohol. While alcohol is adequate to kill many pathogens, it is destructive to acrylic and can produce flammable fumes and vapors creating a fire hazard in the chamber and the immediate area. Therefore, only manufacturer approved cleaning products are used for disinfection of the hyperbaric chamber and accompanying equipment. Particular cleaning and disinfecting tasks are divided among staff from environmental services, equipment or biomedical device services, respiratory services, nursing, and other departments of the health care team.
      • Adverse outcomes related the risk of infection stands at the forefront of concern for post surgical patients.  Infection can lead to poor healing outcomes of skin grafts and flaps.  Particular attention should be given to cleaning and disinfection of the hyperbaric chamber acrylic, stretcher and associated equipment, including observing the specific kill times of the solution used prior to the delivery HBOT. See topic: "Cleaning and Disinfection of Hyperbaric Oxygen Monoplace Chamber"  

      Barotrauma

      • Assessment of the patient and their past medical history is necessary to identify and minimize the risk of barotraumas. If the patient has history of sinus, tooth, and ear problems, compress slowly and observe patient for signs of pain.
      • Middle-ear barotrauma: The most common type of barotrauma experienced by patients receiving HBOT is middle-ear barotrauma (MEB). Normally, the middle ear is a closed, vascular lined space and therefore subject to pressure change. The normal means by which the middle ear remains at an equal pressure with the surrounding tissue is through the opening of the Eustachian tube. During descent, the increasing pressure of the surrounding water leads to “middle-ear squeeze.” If a patient is suffering from Eustachian tube dysfunction, he or she likely will be unable to equalize and will subsequently develop middle-ear barotrauma.[6] 
      • Pneumothorax: A complete and accurate pulmonary assessment is essential to avoid or prevent gas expansion problems. Assessing the patient with a significant pulmonary history is a key starting point. Identify any history of asthma, chronic obstructive pulmonary dysfunction (COPD), fibrosis, spontaneous pneumothorax, or chest trauma.
        • The absolute contraindication for HBOT is the unvented pneumothorax. 
        • Signs and symptoms of pneumothorax include: Sudden shortness of breath, Sudden stabbing chest pain, Tracheal shift to affected side in cases of tension, Asymmetrical chest movement (lack or reduced chest excursion on affected side), Increase in respiratory distress with decompression, with relief on recompression. [6]

      Blood Glucose Level and HBOT

      • It necessary to ensure that all patients who are currently being treated for irregular blood glucose levels do not experience a hypoglycemic event as a result of ongoing HBOT. Most studies suggest that blood glucose decreases in patients with diabetes who undergo HBOT. This decrease in blood glucose is estimated at 50 mg/dl. HBOT might not be as effective in patients with non-insulin dependent diabetes mellitus patients, compared to patients without diabetes. [6]
      • If diabetes mellitus is present, blood glucose should be checked within 1 hour prior to treatment and immediately post-HBOT. The goal is to ensure that all patients who are currently being treated, do not experience a hypoglycemic event as a result of ongoing HBOT.  Hypoglycemia in the hyperbaric environment may present similar symptoms as oxygen toxicity, including but not limited to sweating, pale skin, shakiness, anxiety, tingling or numbness of the tongue or cheek. See section 'Blood Glucose Level and HBOT' in topic "Patient Care".

      Medications in the hyperbaric environment 

      • The hyperbaric environment creates numerous considerations for the use of drug therapies within it. Physiologic changes to the body due to HBOT may lead to pharmacokinetic changes in drug disposition.  In addition, HBO acting as a drug can interact and enhance or lessen the physiologic effect of the drug. Most drugs will not interact unfavorably with oxygen. Unless specific contraindications or precautions have been addressed, it is generally safe to assume a medication can be used.[3]  Pharmacodynamic interactions result in modification of the pharmacologic effect of the drug after administration. These interactions will increase or decrease the effects of oxygen or the drug.[3] 
      • For potential interactions of drugs administered to patients with compromised skin grafts and flaps, see topic "Medications In The Hyperbaric Environment".

      Oxygen Toxicity

      • The hyperbaric staff should be skilled in reducing the potential for and management of oxygen toxicity for the patient receiving HBOT. 
      • Central Nervous System (CNS) oxygen toxicity can occur in patients breathing oxygen at pressures of 2.0 ATA (atmosphere absolute) or greater. Convulsions may occur abruptly or may be preceded by other signs of central nervous system irritability.[3] Early estimates of the seizure rate during therapeutic oxygen exposures at 2-3 ATA reported a convulsion incidence of about one per 10,000 therapies or 0.01%. [6]
      • The hyperbaric physician will be notified immediately if a patient experiences signs or symptoms of oxygen toxicity during HBOT.

      CNS toxicity

      • Observe patient closely for premonitory signs and symptoms of CNS Oxygen Toxicity such as:
        • V : vision-visual changes, blurred vision, visual hallucinations
        • E : Ears- Auditory hallucinations, ringing in the ears
        • N : Nausea- May include emesis
        • T : Twitching- Restlessness, numbness, focal twitching (note time, duration and site)
        • I : irritability- Change in personality
        • D : Dizziness- Vertigo
        • C : Convulsions- Seizure activity
        • C : Change in mentation - Change in affect
        • or of a non-descriptive complaint like, “I just don’t feel right” [2]

      Pulmonary Oxygen Toxicity

      • Most current applications of HBOT do not cause pulmonary symptoms or clinically significant pulmonary functional deficits.[19]  Prolonged exposure to oxygen pressures greater than 0.5 ATA is associated with the development of intratracheal and bronchial irritation.  Pulmonary oxygen toxicity is not expected from routine daily HBOT. The possibility of development does exist with prolonged exposure most typically related to long treatment tables such as US Navy Treatment Table 6 used for decompression illness, but even these cases would be mild and self-limiting.[20]  
        Continued oxygen exposure may lead to impaired pulmonary function and eventually Acute respiratory distress syndrome (ARDS). Symptoms include:
        • Substernal burning,
        • Chest tightness
        • Cough
        • Dyspnea
      • These changes are seen over the course of days to weeks at lower oxygen pressures and occur more rapidly as the oxygen pressure is increased. [6]

      Ocular Oxygen Toxicity

      • Vision changes as a side effect of HBOT have been observed in patients undergoing prolonged periods of daily HBOT.  The rate of these changes has been reported in the literature to be ∼0.25 diopter per week and progressive throughout the course of ongoing treatment. Myopia has been reported in 25–100% of patients undergoing HBOT after several weeks at pressures of 2.0 ATA and greater. [20]  When providing HBO for the patient being treated for a compromised graft or flap it is important to discuss the risks, hazards and potential side effects with the patient and family.  Documentation of this discussion and patient/ family's understanding should be clearly stated in the patient record.  For further information See topic: "Hyperbaric Oxygen Therapy and Visual Acuity" 

      NURSING INTERVENTIONS

      Nursing interventions that are relevant for adjunct HBOT for compromised skin grafts and flaps are presented below. [21] For further information see topic "Nursing Interventions".

      Knowledge deficit related to hyperbaric oxygen therapy and treatment procedures

      • Assess and document the patient and/or family's understanding of purpose and goals of hyperbaric oxygen therapy (HBO), procedures involved, and potential hazards of HBO. Utilize the teach-back method to confirm patient understanding and identify and address barriers to learning. Involve an interpreter if indicated, apply age-specific teaching, consider cultural/religious factors, assess readiness to learn, and identify patient's expectations of treatment. 
      • See section 'Knowledge deficit related to hyperbaric oxygen therapy and treatment procedures' in topic "Nursing Intervention"

      Anxiety related to hyperbaric oxygen treatments or other medical problems 

      • Assess the patient for a history of confinement anxiety and implement preventative measures as appropriate. It is important to reinforce to patient that someone will always be with them, and the staff are well trained for emergency procedures. Identify signs of symptoms of anxiety before and during HBO treatment such as:
        • Patient states they are anxious
        • Tense appearing facial/body posturing
        • Complaint of nausea or diarrhea
        • Feelings of being confined or smothered
        • Defensive or argumentative attitude
        • Hyperventilation
        • Diaphoresis and hyperventilation
        • Tachycardia
        • Restlessness
        • Sudden feeling of being hot
      • See section 'Anxiety related to hyperbaric oxygen treatments or other medical problems' in topic "Nursing Intervention"

      Potential for injury within the hyperbaric facility related to transferring the patient in and out of the chamber

      • When transferring a patient that is being treated for a compromised skin graft of flap, comply with the facility's fall risk prevention policy.  Prior to transfer of the patient assess fall risk and safety precautions.  Communicate and involve patient with the plan of action and provide patient education regarding safety precautions.  Provide assistance with transfers as patient needs apply to ensure compliance with institutional/facility policy. 

      Potential for injury related to fire within the hyperbaric chamber

      • Fuel sources in an oxygen-enriched environment are an unavoidable circumstance of HBOT and include linens, equipment, dressings, and the patient.  The fire triangle consists of oxygen, fuel, and an ignition source(heat).  In HBOT an ignition source is needed to complete the fire triangle. This may occur due to a spark in the chamber. Follow facility fire prevention steps and NFPA chapter 14 probes for Class A and Class B hyperbaric chambers. HBOT teaching and consent should include the risks of fire in the chamber.  Provide the patient and family with written instructions regarding the risk of prohibited materials during HBOT.  Prior to each hyperbaric treatment, staff should perform and document the pre-treatment safety checklist. Ensure this has been performed and time-stamped prior to descent.  Patients receiving treatment for a compromised skin graft or flap may have surgical dressings that are ordered to remain intact.  A risk assessment per the Safety Director in collaboration with the Medical Director to determine if they may enter the chamber on a case by case basis. Safety measures should be initiated if the risk assessment allows for item to enter the chamber as well as completion of a prohibited item's authorization form signed by the Safety and Medical Directors.

      Potential for injury related to changes in atmospheric pressure within the hyperbaric chamber

      • Assess patient's and inside attendant's knowledge of ear clearing techniques and ability to equalize pressure.  Collaborate with provider to assess tympanic membrane (TM) for suspected barotrauma prior to and after the first HBO treatment and per patient complaint.  Collaborate with the provider to describe and document observations including color and visibility of TM, presence of wax, blood/fluid/air and any hearing deficits or changes.   Methods to equalize pressure in the middle ear during HBO treatment include: yawning, swallowing, jaw thrust, head tilt, Valsalva, Toynbee, Roydhouse, Frenzel, etc..  Reinforce the importance of notifying the chamber operator immediately when pressure or fullness is felt in the middle ear.

      Imbalanced nutrition/less than body requirements related to intake of nutrients insufficient to meet metabolic needs

      • Patient's nutrient intake must be sufficient to meet basal needs and improve healing.  It is well documented that wound healing is impaired  without sufficient metabolic energy and nutrients. The patients baseline nutritional status should be assessed initiating adjunctive HBO.  The need for nutritional supplementation should be coordinated with the primary care physician and/or referring service.  Provide nutritional education with consideration to the patient's needs and dietary preferences. For more information see topic: "Nutritional Screening for Wound Care and Hyperbaric Oxygen Therapy".

      Potential for unstable blood glucose level related to hyperbaric oxygen therapy and disease pathology

      • Literature notes hyperbaric oxygen therapy carries its own mechanism for increased glucose usage through oxygen-mediated transport of glucose into muscle cells and may also increase insulin sensitivity.  Prevention of acute hypoglycemia in the hyperbaric chamber is vital for patient safety.  Follow facility policy and procedure guidelines for pre and post-treatment glucose control.  Prior to treatment assess the patient's knowledge level, recent hypoglycemic events, and patient-specific symptoms of hypoglycemia.  Proper glucose control < 200mg/dL is vital for wound healing.  Consider timing of short and long-acting glycemic control medications when scheduling HBO to avoid peak action time while at depth in the chamber 

      CODING

      • See topic "ICD-10 Coding"

      COVERAGE AND REIMBURSEMENT

      • Medicare Coverage Criteria: HBOT is utilized for graft or flap salvage in cases where hypoxia or decreased perfusion has compromised the viability of an existing skin graft or flap. Medicare coverage does not apply to the initial preparation of the body site for a graft. HBOT is not necessary for normal, uncompromised skin grafts or flaps, for primary management of wounds, or dehiscence of surgical wounds not related to a flap surgery. Clinicians should review and document the medical necessity for the use of HBOT for more than 20-25 treatments, regardless of the condition of the patient. The documentation present in the clinical record must provide an accurate description and diagnosis of the medical condition supporting that the continued use of HBOT is reasonable and medically necessary.[1]  See HBO Request Requirements Checklist


        APPENDIX

        Summary of Evidence

        We reviewed the clinical guidelines, systematic reviews, meta-analyses and clinical trials summarized below. Applying the GRADE framework to the combined body of evidence, we found that:

        • Low certainty evidence supports the use of HBOT to salvage compromised flaps and grafts (evidence level C), drawn from animal studies, observational studies and many case series. There have been no randomized controlled trials (RCTs) that addressed the use of HBOT to salvage compromised flaps and grafts to date. Only 1 RCT studied HBOT on the survival of skin grafts, however all patients with skin grafts (not only compromised skin grafts) were included, and the RCT was considered at high risk of bias due to lack of inadequate patient blinding, incomplete outcome data, and selective reporting [16] 

        - Systematic reviews and meta-analyses

        • No systematic reviews or meta-analyses on HBO as an adjunctive therapy to treat compromised flaps and grafts were found

        - Clinical guidelines

        • The 2014 Undersea and Hyperbaric Medicine Society (UHMS) [4] and the 2017 European Committee for Hyperbaric Medicine (ECHM) [22] guidelines support the use of HBO for the salvage of compromised skin flaps and grafts. The UHMS issued a Class 1b based on an RCT that included 48 patients who underwent skin grafting and received HBO treatment to increase the survival rate. Authors state that all patients with skin graft were included, and not only the ones with compromised graft take. (Perrins, 1967)
        Intervention UHMS ECHM
        HBO for the salvage of compromised skin flaps and grafts AHA Class 1b Grade 2C

        -  Randomized controlled trials (RCTs): 

        • No RCTs on HBOT as an adjunctive therapy to treat compromised flaps and grafts were found. There were other RCTs on use of HBOT to increase survival rate of flaps and grafts.[15]

        - Observational studies and case series: 

        •  Many observational studies and case series reported improved survival rates when using HBOT for the salvage of compromised skin flaps and grafts.[23][24][25][10][11][12][13][14][26]

        CATEGORY A CONTINUING EDUCATION CREDIT

        This topic has been reviewed and approved by the National Board of Diving and Hyperbaric Medical Technology (NBDHMT) for one (1) Category A Credit. 'Meeting the Category A requirement related directly to any combination of hyperbaric operations, related technical aspects and chamber safety.'

        To claim the credit: 

        1. Read the topic
        2. Answer the examination and course critique questions. See "Compromised Skin Grafts and Flaps - Examination and Course Critique Questions" 
        3. Receive the certificate by e-mail. A passing score of 70% is required (please allow up to 8 business days for processing)

        For more information on Category A continuing education credits see blog post " Hyperbaric Certification and Continuing Education for Technicians & Nurses".

        REVISION UPDATES

        DateDescription
        6/9/20Added Category A Continuing Education Credit by the NBDHMT
        5/10/20Added sections on Operational Considerations and Nursing Interventions for CHTs and CHRNs
        4/22/19Added section on Coverage and Reimbursement. Added additional documentation statements in the section on Documentation
        Official reprint from WoundReference® woundreference.com ©2018 Wound Reference, Inc. All Rights Reserved
        Use of WoundReference is subject to the Subscription and License Agreement. ​
        NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

        REFERENCES

        1. CMS. National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . 2017;.
        2. Chiang IH, Tzeng YS, Chang SC et al. Is hyperbaric oxygen therapy indispensable for saving mutilated hand injuries? International wound journal. 2017;volume 14(6):929-936.
        3. Francis A, Baynosa RC et al. Hyperbaric Oxygen Therapy for the Compromised Graft or Flap. Advances in wound care. 2017;volume 6(1):23-32.
        4. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Committee,, et al. Hyperbaric Oxygen Therapy Indications . 2014;.
        5. Kiyoshige Y. Effect of hyperbaric oxygen therapy as a monitoring technique for digital replantation survival. Journal of reconstructive microsurgery. 1999;volume 15(5):327-30.
        6. Harry T. Whelan, Eric Kindwall et al. Hyperbaric Medicine Practice 4th Edition Best Publishing Company. 2017;.
        7. Kleban, S MD, Baynosa, R MD et al. Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Indications, 14th edition: The Effects of Hyperbaric Oxygen on Compromised Grafts and Flaps . 2019;.
        8. National Baromedical Services. Introduction to Hyperbaric Medicine Primary Training Manual .;.
        9. Moffat AD, Worth ER, Weaver LK et al. Glycosylated hemoglobin and hyperbaric oxygen coverage denials. Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, In.... 2015;volume 42(3):197-204.
        10. Fredman R, Wise I, Friedman T, Heller L, Karni T et al. Skin-sparing mastectomy flap ischemia salvage using urgent hyperbaric chamber oxygen therapy: a case report. Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, In.... 2014;volume 41(2):145-7.
        11. Larson JV, Steensma EA, Flikkema RM, Norman EM et al. The application of hyperbaric oxygen therapy in the management of compromised flaps. Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, In.... 2013;volume 40(6):499-504.
        12. Roje Z, Roje Z, Eterović D, Druzijanić N, Petrićević A, Roje T, Capkun V et al. Influence of adjuvant hyperbaric oxygen therapy on short-term complications during surgical reconstruction of upper and lower extremity war injuries: retrospective cohort study. Croatian medical journal. 2008;volume 49(2):224-32.
        13. Friedman HI, Stonerock C, Brill A et al. Composite earlobe grafts to reconstruct the lateral nasal ala and sill. Annals of plastic surgery. 2003;volume 50(3):275-81; discussion 281.
        14. Saber AA, Yahya KZ, Rao A, Castellano M, Cioroiu M, Grossi R, Tornambe RM et al. A new approach in the management of chronic nonhealing leg ulcers. Journal of investigative surgery : the official journal of the Academy of Surgical Research. 2005;volume 18(6):321-3.
        15. Perrins DJ. Influence of hyperbaric oxygen on the survival of split skin grafts. Lancet (London, England). 1967;volume 1(7495):868-71.
        16. Eskes A, Vermeulen H, Lucas C, Ubbink DT et al. Hyperbaric oxygen therapy for treating acute surgical and traumatic wounds. The Cochrane database of systematic reviews. 2013;.
        17. National Fire Protection Association. "Hyperbaric Facilities" Chapter 14, NFPA 99 Health Care Facilities, 2018 Edition. . 2018;.
        18. Lambertsen CJ, Dough RH, Cooper DY, Emmel GL, Loeschcke HH, Schmidt CF et al. Oxygen toxicity; effects in man of oxygen inhalation at 1 and 3.5 atmospheres upon blood gas transport, cerebral circulation and cerebral metabolism. Journal of Applied Physiology. 1953;volume 5(9):471-86.
        19. E. Thorsen, L. Aanderud, T.B. Aasen et al. Effects of a standard hyperbaric oxygen treatment protocol on pulmonary function. European Respiratory Journal. 1998;.
        20. Heyboer, Marvin; Sharma, Deepali; Santiago, William; McCulloch, Norman et al. Hyperbaric oxygen therapy: side effects defined and quantified. Advances in Wound Care. 2017;volume 6(6):210-224.
        21. Baromedical Nurses Association. Baromedical Nurses Association Guidelines of Nursing Care for the Patient Receiving Hyperbaric Oxygen Therapy . 2018;.
        22. Mathieu, Daniel; Marroni, Alessandro; Kot, Jacek et al. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving and hyperbaric medicine. 2017;volume 47(1):24-32.
        23. Mathieu D, Neviere R, Pellerin P, Patenotre P, Wattel F et al. Pedicle musculocutaneous flap transplantation: prediction of final outcome by transcutaneous oxygen measurements in hyperbaric oxygen. Plastic and reconstructive surgery. 1993;volume 91(2):329-34.
        24. Assaad NN, Chong R, Tat LT, Bennett MH, Coroneo MT et al. Use of adjuvant hyperbaric oxygen therapy to support limbal conjunctival graft in the management of recurrent pterygium. Cornea. 2011;volume 30(1):7-10.
        25. Gould LJ, May T et al. The Science of Hyperbaric Oxygen for Flaps and Grafts. Surgical technology international. 2016;volume 28():65-72.
        26. Lee Y, Heo JW, Moon JS, Kim SW, Kim J et al. Effects of hyperbaric oxygen on graft survival outcomes in composite grafting for amputated fingertip injury. Archives of plastic surgery. 2020;volume 47(5):444-450.
        Topic 436 Version 5.0

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