WoundReference improves clinical decisions
 Choose the role that best describes you
WoundReference logo

Clostridial Myonecrosis (Gas Gangrene)

Clostridial Myonecrosis (Gas Gangrene)

Clostridial Myonecrosis (Gas Gangrene)

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). This discussion covers the Gas Gangrene (Clostridial Myonecrosis) diagnosis. 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.” 

The following 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


 Sample Physician Order   | $ ICD-10 Crosswalk   |  Treatment Table   Emergent / Urgent Indication 

Background Gas gangrene (also known as clostridial myositis, clostridial myonecrosis, or spreading clostridial cellulitis with systemic toxicity) is an acute, rapidly progressive, non-pyogenic, invasive clostridial infection of the muscles, characterized by profound toxemia, extensive edema, massive death of tissue, and a variable degree of gas production. Alpha and theta toxins, produced by Clostridium species, are directly involved in the pathogenesis of clostridial myonecrosis. Hyperbaric oxygen should not be used alone but is adjunctive to aggressive surgical and medical management. Early HBOT may reduce complexity of surgical procedures and prevent (or limit) major amputations. Regardless of HBOT involvement, mortality can be quite high in this patient population.

Goals of HBOT

  • Increase tissue oxygen levels to more than 250 mmHg, thus reaching levels to stop the alpha-toxin activity  
  • Decrease production of toxins through the bacteriocidal/bacteriostatic effects on Clostridium species    
  • Augment antibiotic therapy, accelerate demarcation between potentially viable and non-viable tissue within 24 - 30 hours, thus reducing the total amount of tissue lost           

Diagnosis

Definitive diagnosis requires demonstration of Clostridial species (gram-positive, spore-forming, not motile, rod-shaped organisms). Clinical signs include systemic toxicity (fever, malaise), local pain (especially in the absence of trauma), and tissue crepitus (presence of gas in soft tissues on physical exam or confirmed with imaging) 

HBOT Criteria
  • Clinical signs of gas gangrene as described above
  • Positive Gram-stained smear of the wound fluid (without leukocytes)
  • Microscopic evaluation showing necrotizing and degenerating muscle tissue 

Evaluation

  • STAT Surgical consultation unless patient referred to HBOT for consultation
  • Typically, these patients are inpatient receiving critical care, therefore monitoring blood pressure, electrocardiogram (ECG), Ventilatory support, Intravenous fluids (vasopressors) and urinary output (Foley catheter) may be necessary
  • Past medical history (look for history of recent traumatic wound or surgery)
  • Physical examination (direct examination of involved tissues with findings described above)
  • Labs to order (Pending lab results should not delay the start of HBOT)
    • Complete Blood Count (CBC)
    • Arterial Blood Gas (ABG)
    • Blood chemistry profile (BCP)
    • C-reactive protein (CRP)
    • Urinalysis/Urine Myoglobin and Hemoglobin
    • Disseminated Intravascular Coagulation (DIC) profile
    • Punch Biopsy (or direct surgical pathology tissue)
    • Culture and Sensitivity (C&S); gram stain.
    • Tissue culture from OR, if possible.
  • Imaging:
    • X-Ray (may or may not see fascial bubbles)
    • Ultrasound, computerized tomography (CT), magnetic resonance imaging (MRI)
  • ECG
  • Daily wound evaluation and weekly photography 
  • Transcutaneous oxygen (TCOM) assessment to determine tissue oxygenation (if possible)
  • Evaluation of tympanic membranes pre-HBO and as needed. Consider emergent myringotomies

Treatment

  • 3.0 ATA for 90 minutes of oxygen breathing (Table 4a) with 2 ten-minute air breaks at the 30 and 60-minute mark
  • 3 treatments are given within the first 24 hours. Avoid delays greater than 6 hours between each treatment, if at all possible.
  • Continue treatment twice daily post 24 hours up to 72 hours. Once the advancing necrosis has stopped, treatment pressures may be reduced to 2.4 ATA.
  • The wound will be serially monitored with the surgeon and infectious disease consultant    
  • Once the infection has stabilized and no further surgical debridements are necessary, the patient will be treated daily at 2.0 ATA for 90 minutes of oxygen breathing for 7-10 days.
  • If the patient shows evidence of deterioration, the more aggressive twice daily treatments can be extended or renewed.
  • These patients are typically inpatient receiving critical care, therefore, ventilatory support, blood pressure (arterial line), central pressures (Swan Ganz), ECG, and urinary output may be monitored as directed
  • Continue daily wound assessment with photography
  • The decision to discontinue HBOT will be based upon the patient's response to HBO therapy, findings at repeat wound debridement and assessment, and the absence of hemolysis and myonecrosis. This decision will be made in conjunction with the patient‟s surgical specialists. 

Follow-Up

  • Wound assessment and photography 
  • If reconstructive skin grafting or flapping is performed, consider additional HBOT for compromised recipient bed.

Treatment Threshold

Concurrent review (After 10 total treatments); Third party review after15 treatments

Coding

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

Comments

  • Although a three-pronged approach consisting of HBOT, surgery, and antibiotics is essential in treating gas gangrene, initial surgery can be restricted to opening of the wound. An initial fasciotomy may be undertaken but lengthy and extensive procedures in these very ill patients can usually be postponed, depending on how rapidly HBOT can be started. Debridement of necrotic tissue can be performed in between HBO treatments and should be delayed until clear demarcation between dead and viable tissue can be seen. It is not uncommon for these patients to have daily surgical debridement. Due to the nature of the bacterial disease, these surgeries would be performed as 'last cases' in operating rooms, so that the OR suite can be adequately disinfected/cleaned.
  • If diabetes mellitus, blood glucose should be checked within an hour prior to treatment and again immediately post-HBOT. 
  • Avoid petroleum-based dressings and ointments whenever possible. If these are a necessary part of the surgical dressing, ensure that they are not exposed and are completely covered with 100% cotton.
Primary Sources: Whelan and Kindwall [2]Weaver [3]

DOCUMENTATION

History

Sample history of present illness (HPI) for Clostridial Gas Gangrene is provided below: 

"Sally S. is a 13-year-old female who was playing a "scratching game" with friends. Apparently, the youths take a safety pin or other sharp object and scratch initials on the forearm of another person. She was doing this yesterday afternoon. By midnight, she could not sleep and complained of excruciating pain on her left forearm with some swelling and skin changes. Her parents were concerned and brought her to the emergency room. 

The emergency room physician noted bronze colored bullae on the forearm with evidence of advancing infection. An x-ray of the arm was taken and demonstrated gas bubbles in the tissue planes of the distal left arm. A bullous ruptured and ER doctor noted "dishwater" fluid exuding from the skin. By the time the patient reached the emergency room, she could no longer make a fist or purposefully use her hand. A general surgeon and hand surgeon were called for consultation. By the time they arrived the advancing infection was just below the elbow. A presumptive diagnosis of Clostridial myonecrosis was made and emergency surgery for debridement and limb salvage planned.

In the operating room, the tissue destruction had evolved to the mid-biceps region. There was extensive tissue damage to the distal arm and considerable doubt about long-term viability. This is a limb and life-threatening infection. Tissue cultures have been sent. The clinical picture is one of Clostridial Gas Gangrene. A gram stain in the operating room showed scant organisms, but predominantly gram-positive rods. 

The patient remained intubated in the recovery room, and intensive care for sepsis and aggressive fluid management continues. We were consulted when the patient was taken to the operating room. We called in the critical care hyperbaric medicine team in order to treat this patient as soon as possible after surgery. We intend to treat this patient with adjunctive hyperbaric oxygen in order to stop the advancement of the toxins causing tissue destruction."

Physical Exam

Clinical signs include:

  • Systemic toxicity (fever, malaise)
  • Local pain (especially in the absence of trauma), and
  • Tissue crepitus (presence of gas in soft tissues on physical exam or confirmed with imaging) 

Gram stain of wound fluid shows:

  • Clostridial species (gram-positive, spore-forming, not motile, rod-shaped organisms) in wound fluid.

Impression

  • Clostridial Myonecrosis (Gas Gangrene) Refer to ICD-10 Crosswalk

Plan

A typical hyperbaric regimen for a patient diagnosed with gas gangrene consists of an aggressive treatment protocol of a 3.0 ATA pressure with 90 minutes of oxygen breathing administered 3 times in the first 24 hours followed by twice daily treatments. The wound will be serially monitored with the surgeon and infectious disease consultant. This schedule is usually continued for 48-72 hours. Once the infection has stabilized and no further surgical debridements are necessary, the patient will be treated daily at 2.0 or 2.4 ATA for 90-120 minutes of oxygen breathing for several additional days. If the patient shows evidence of deterioration, the more aggressive twice daily treatments can be extended or renewed.

Risk and Benefit of Hyperbaric Oxygen Therapy 

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

Indication for Hyperbaric Oxygen Therapy (HBOT)

The paragraphs below serve as documentation statements to support indication of HBOT as an adjunctive treatment of Gas Gangrene"

"Gas gangrene (also known as clostridial myositis, clostridial myonecrosis, or spreading clostridial cellulitis with systemic toxicity) is an acute, rapidly progressive, non-pyogenic, invasive clostridial infection of the muscles, characterized by profound toxemia, extensive edema, massive death of tissue, and a variable degree of gas production. The infection is caused by anaerobic, spore-forming, Gram-positive, encapsulated bacilli. The most common organism is Clostridium perfringens, however, there are more than 150 clostridial species which can cause the disease. While there are many toxins produced in this infection, the alpha-toxin (lecithinase and phospholipase-C) cause most of the tissue destruction. 

Hyperbaric oxygen therapy increases tissue oxygen levels to more than 250 mmHg, thus reaching levels to stop the alpha-toxin activity. Hyperbaric oxygen has been shown to be bacteriocidal/bacteriostatic to the Clostridium organisms. Hyperbaric oxygen should not be used alone, however, is adjunctive to aggressive surgical and medical management. Early hyperbaric oxygen treatment is 1) lifesaving because less heroic surgery needs to be performed, and 2) it is limb- and tissue-saving because no major amputations are performed prematurely. Hyperbaric oxygen treatments clarify the demarcation between viable and dead tissue, thus the total amount of tissue lost is greatly reduced."

Sample Order

  •  See Sample Physician Order

CLINICAL EVIDENCE AND RECOMMENDATIONS 

  • 2C For patients with gas gangrene, we suggest use of adjunct HBOT in addition to standard care (i.e., surgical debridement, ICU care and appropriate antibiotics) to help symptoms and signs of gas gangrene subside, instead of standard care alone.(Grade 2C)
    • RationaleEvidence for the use of adjunctive HBOT has been published through case reports and small case series, through which there have been hundreds of patients survive serious gas gangrene infection with adjunctive HBOT. As far as we are aware, there have been no randomized trials using adjunctive HBOT.[4] In fact, given the number of case and case series reports, a randomized trial may be unethical. As a result, the gas gangrene (Clostridial myonecrosis) indication was added to the list of "UHMS Approved" indications in the late 1970s. Related research showed that tissue oxygen levels must approach (or be higher than) 300 mmHg for gas gangrene to be treated. Researchers at Duke University also demonstrated in their 49 patient case series that 3 ATA hyperbaric oxygen treatment was required for the best outcome when treating gas gangrene.[5] Although no RCTs comparing standard care with or without adjunct systemic HBOT to treat gas gangrene have been published to date, we identified one RCT that compares systemic HBOT plus standard care with Topical Oxygen (TopOx) plus standard care.[6] A Cochrane review found no evidence of difference between the two groups; RR of 1.10 (95% CI 0.25 to 4.84) and concluded that the review did not show beneficial effects of additional use of TopOx on treating gas gangrene. Evidence was considered of very low quality due to risk of bias and imprecision.[7] 
    • Coverage: Adjunct HBOT is covered by Medicare for treatment of gas gangrene. Concurrent review is recommended after 10 total treatments and third party review after15 treatments

SUMMARY OF EVIDENCE

(back to text)

Systematic reviews and meta-analyses 

  • A 2015 Cochrane review [7] evaluated use of HBOT as an adjunctive intervention for gas gangrene. Authors identified only 1 RCT [6] that compared 10 days of topical oxygen (TopOx) and standard care (debridement and antibiotic therapy) with 10 days of systemic HBOT and standard care. Authors found no evidence of difference between the two groups; RR of 1.10 (95% CI 0.25 to 4.84). According to the GRADE assessment, evidence was considered of very low quality due to risk of bias and imprecision. Of note, the RCT did not compare adjunctive use of systemic HBOT plus standard care with standard care only.  

REVISION UPDATES

DateDescription
6/11/19Added section on Clinical Evidence and Recommendations
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. Harry T. Whelan, Eric Kindwall et al. Hyperbaric Medicine Practice 4th Edition Best Publishing Company. 2017;volume fourth():.
  3. Dirk J Bakker, MD, PhD et al. Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Indications, 13th edition: Clostridial Myonecrosis (Gas Gangrene) . 2014;.
  4. Bakker DJ. Clostridial myonecrosis (gas gangrene). Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, In.... 2012;volume 39(3):731-7.
  5. Holland JA, Hill GB, Wolfe WG, Osterhout S, Saltzman HA, Brown IW Jr et al. Experimental and clinical experience with hyperbaric oxygen in the treatment of clostridial myonecrosis. Surgery. 1975;volume 77(1):75-85.
  6. Li Y, Ma Z, Cao Y. et al. Effect of localized hyperbaric oxygenation on gas gangrene [in Chinese]. Modern Diagnosis and Treatment. 2001;volume 12(4):229-30.
  7. Yang Z, Hu J, Qu Y, Sun F, Leng X, Li H, Zhan S et al. Interventions for treating gas gangrene. The Cochrane database of systematic reviews. 2015;.
Topic 603 Version 5.0