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Necrotizing Soft Tissue Infections And Fournier's Gangrene

Necrotizing Soft Tissue Infections And Fournier's Gangrene

Necrotizing Soft Tissue Infections And Fournier's 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 will include Necrotizing Soft Tissue Infections, including Fornier's Gangrene. 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 conditions meet coverage indications per the National Coverage Determination (NCD) 20.29.[1] Continued HBO therapy 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   Urgent Indication 

Background Hyperbaric oxygen therapy is an accepted adjunct to surgical and antibiotic treatment for necrotizing soft tissue infections.  Infections frequently cause local hypoxia and an infection-induced occlusive endarteritis. This hypoxic condition profoundly impairs leukocyte function. Necrotizing fasciitis is usually (50-90%) caused by a mixed bacterial culture with a predominance of Group A, C, or G beta-hemolytic Streptococcus. These micro-organisms cause a toxin-induced hypoxia of the fascial plane, resulting from an aggregation of platelets and neutrophils. There can be necrotizing fasciitis caused by MRSA alone, but this is rare. It is not uncommon to also culture Candida, Enterobacter, and obligate anaerobes. Necrotizing fasciitis of the groin or genitals is known as Fornier's gangrene.

Goals of HBO

    • Limit spread of infection by increasing local tissue oxygen levels and reducing the degree of hypoxic leukocyte dysfunction, thud stopping toxin production.
    • Enhance antibiotic action (if antibiotic requires oxygen for transport across the bacterial wall)
    • Accelerate demarcation of potentially viable from non-viable tissue

      Diagnosis

      • Definitive diagnosis is surgical, with friability of superficial fascia, dishwasher gray exudate, and no purulence. Exploratory surgery should not be delayed when necrotizing soft tissue infection is suspected based on the clinical findings below. [2]
      • Clinical signs of necrotizing soft tissue infection include:
        • Soft tissue edema, erythema, severe pain (pain out of proportion to findings is an early indicator of deep fascial infection)
        • Systemic illness (fever, hypotension or hemodynamic instability). Septic shock is not uncommon early in the disease process.
        • Findings commonly associated with necrotizing soft tissue infection:
          • Crepitus, tissue necrosis, putrid discharge
          • Gas production (may/nay not be visible on x-ray)
          • Infections burrowing through soft tissue and fascial planes
          • Rapid deterioration of clinical condition
      • Radiographic studies will show soft tissue swelling with or without gas in tissue

      Hyperbaric

      Criteria

      • Diagnosis of necrotizing soft tissue infection
      • Aggressively spreading soft tissue infections despite appropriate antibiotic therapy and adequate operative debridement.
      • Actual tissue cultures may have been taken but no results will be available for most of these patients early on.
      • This is generally a diagnosis that the surgeon recognizes in the operating room.

      Evaluation

      • Typically, these patients are inpatient receiving critical care, therefore monitoring of vital signs, ventilatory support, intravenous fluids (vasopressors) and urinary output may be necessary
      • Past medical history
      • Physical examination
      • Surgical consultation and
      • Labs to order:
        • Complete Blood Count (CBC)
        • Blood chemistry profile (BCP)
        • C-reactive protein (CRP)
        • Urinalysis
        • Arterial Blood Gas (ABG)
      • Punch Biopsy (or any surgical specimen biopsy)
      • Culture and Sensitivity (C&S)
        • Aerobic and anaerobic; gram stain
        • Tissue culture from OR, if possible.
        • Fungal cultures in the immunocompromised, cancer populations, and patients unresponsive to standard antibiotic therapy
      • Imaging:
        • X-ray
        • Ultrasound, Computerized Tomography (CT), Magnetic Resonance Imaging (MRI)
      • Electrocardiogram (ECG)
      • Daily wound evaluation and weekly photography 
      • Transcutaneous oxygen assessment to determine tissue oxygenation (if indicated)
      • Evaluation of tympanic membranes pre-HBOT and as needed

      Treatment

      • 2.0 - 2.5 ATA for 90 minutes of oxygen breathing with 5-10 minute air breaks at 30 and 60-minutes of breathing oxygen (Table 3)
      • 3 treatments are given within the first 24 hours
      • Continue treatment twice daily after the first 24 hours, up to 72 hours
      • Once the infection has stabilized, and there appears to be no further extension of necrosis in previously debrided areas, and infection is controlled, decrease treatment to once daily up to 7-10 days.
      • If the patient shows deterioration, the more aggressive twice daily treatment can be extended or renewed.
      • If there is doubt of the diagnosis, and clostridial myositis and myonecrosis are still in the differential diagnosis, higher pressure treatments to 3.0 ATA should be used following the same treatment schedule above. 
      • The wound will be serially monitored with the surgeon and Infectious disease consultant
      • 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
      • Evaluation of tympanic membranes pre-HBOT and as needed

      Follow-Up

      • Wound assessment and photography 
      • If reconstructive skin grafting or flap surgery is performed, consider additional HBOT for compromised recipient bed.
      • If your wound/HBOT clinic has a plastic surgeon consultant, involve him/her early in the course of treatment in order to plan flaps for closure.

      Treatment Period

      10 – 30 treatments (Third party peer review should be requested after 30 treatments)

      Coding

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

      Comments

      • If diabetes mellitus, blood glucose should be checked within 1 hour prior to, and again immediately post-HBO.
      • 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 [3]Weaver [4]

      DOCUMENTATION

      History 

      Sample history of present illness (HPI) for necrotizing soft tissue infection and Fournier's Gangrene is shown below:

      "Mr. Gomez presents with a brief history of pain in his penis and testicles. In the past 24 hours, he has gone from discomfort in his perineum to exquisite pain, swelling, and foul smelling discharge. The general and urologic surgeons have taken him to the operating room for biopsy and debridement. The debridement was extensive and required sacrificing one testicle, broad debridement that required removing the entire scrotum and removing the skin and subcutaneous tissues of the entire length of his penis. Extensive exploration of the groin required opening the entire left side of his groin in order to expose relatively normal tissue.

      Cultures have been sent and a rapid gram stain showed a mixed gram positive and gram negative cocci in clumps. The surgeons have called this a necrotizing fasciitis and Fournier's gangrene. The hyperbaric service has been asked to provide urgent hyperbaric oxygen support for this condition. The overall plan is for daily surgical debridements until no more necrotic tissue is noted. We will vigorously support the surgeons with twice daily hyperbaric oxygen therapy until the tissue bed is stable.

      Pertinent past history includes Type 2 diabetes mellitus that is under poor control with a Hemoglobin A1c of 12.5%. Mr. Gomez is a problem drinker and admits to 1 pint of Vodka daily. He has more than 5 alcoholic drinks per day, on average. (NOTE that necrotizing fasciitis is commonly seen in patients with Type 2 diabetes mellitus under poor control. It is also commonly associated with alcoholic patients who frequently drink heavily.)"

      Physical Exam

      • Clinical signs of necrotizing soft tissue infection include:
        • Soft tissue edema, erythema, severe pain (pain out of proportion to findings is an early indicator of deep fascial infection)
        • Systemic illness (fever, hypotension or hemodynamic instability). Septic shock is not uncommon early in the disease process.
        • Findings commonly associated with necrotizing soft tissue infection:
          • Crepitus, tissue necrosis, putrid discharge
          • Gas production (may/nay not be visible on x-ray)
          • Infections burrowing through soft tissue and fascial planes
          • Rapid deterioration of clinical condition

      Impression

      Necrotizing Soft Tissue Infections and Fournier's Gangrene - Refer to the ICD-10 Crosswalk 

      Plan

      "A typical hyperbaric regimen for a patient diagnosed with a necrotizing soft tissue infection consists of a treatment protocol of 2.0 or 2.5 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 2.5 ATA for 90 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)

      "Hyperbaric oxygen therapy is an accepted adjunct to surgical and antibiotic treatment for necrotizing soft tissue infections. Such conditions may result from a combination of anaerobic and aerobic bacteria. Necrotizing infections appear in a wide variety of clinical settings, including trauma, surgical wounding, and/or foreign bodies. The patient is frequently compromised with diabetes, vasculopathy, or other immune-affecting diseases. Infections frequently cause local hypoxia and an infection-induced occlusive endarteritis. This hypoxic condition profoundly impairs white blood cell bacterial killing actions. Clinical signs of mixed soft tissue infection include tissue necrosis, a putrid discharge, gas production (often visible on x-ray), and infection burrowing through soft tissue and fascial planes. This is often seen without the typical inflammatory response in severe infections. 

      Hyperbaric oxygen works by increasing local tissue oxygen levels, thus helping white cell-mediated bacterial killing, and by stopping synergistic interaction present in mixed bacterial infections. Aggressive hyperbaric oxygen treatment is clearly recommended for necrotizing fasciitis, Fournier’s gangrene, crepitant anaerobic cellulitis, progressive bacterial gangrene, and non-clostridial myonecrosis (synergistic necrotizing cellulitis)."

      Sample Order

      •  See Sample Physician Order

      REVISION UPDATES

      DateDescription
      4/22/19Added section on Documentation



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      REFERENCES

      1. CMS. National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . 2017;.
      2. Stevens DL, Bryant AE et al. Necrotizing Soft-Tissue Infections. The New England journal of medicine. 2017;volume 377(23):2253-2265.
      3. Harry T. Whelan, Eric Kindwall et al. Hyperbaric Medicine Practice 4th Edition Best Publishing Company. 2017;volume fourth():.
      4. Irving "Jake" Jacoby, MD, FACP, FACEP, FAAEM et al. Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Indications, 13th edition: Necrotizing Soft Tissue Infections . 2014;.
      Topic 606 Version 4.0