VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis

Study Overview
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Brief Summary
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Find out the best management of Necrotizing Fasciitis after surgical debridement

Detailed Description
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Necrotizing fasciitis is a life-threatening condition that can occur as a result of trauma or foreign bodies in surgical wounds as well as idiopathically. Necrotizing fasciitis is characterized by a progressive infection in fascial planes with necrosis of the subcutaneous tissue. Necrotizing fasciitis affects the extremities more frequently than central areas. Risk factors for necrotizing fasciitis include diabetes mellitus, trauma wound infections, decubitus ulcers, alcoholism, carcinoma, peripheral vascular disease, smoking, and intravenous drug abuse. A varieties of micro-organisms, including gram-positive group A streptococcus, haemolytic streptococci, and staphylococcus aureus; gram-negative Enterobacteriaceae, Escherichia coli, Klebsiella spp., and Proteus spp.; anaerobes including Peptostreptococcus, Clostridium, and Pacteroides; and fungi such as Candida and acid-fast bacteria have all been implicated in the pathogenesis of Necrotizing fasciitis. Necrotizing fasciitis is a surgical emergency for detoxification by debridement with good antibiotic coverage. It has mortality rate reaching 20-30% , this mortality rate is high and requires prompt diagnosis, antibiotic treatment and extensive necrosectomy up to intensive care units admission in some cases, the aim of our prospective analysis is to assess with a hypothesis-generating and exploratory purpose the possible role of VAC versus ordinary dressings in the wound therapy of Necrotizing Fasciitis in terms of expected time for wound closure and survival rate.

Official Title
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Comparative Study Between Vacuum Assisted Closure (VAC) and Conventional Dressing in the Healing Process of Necrotizing Fasciitis After Surgical Debridement.. Clinical and Laboratory Study.

Conditions
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Necrotizing Fascitis

Intervention / Treatment
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* Device: VAC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Immunocompromised patients such as; diabetic, HIV and leukaemia. And other chronic debilitating diseases. Exclusion Criteria: Necrotizing Fasciitis of Head and neck and upper limbs.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vacuum Assisted Closure device<br>Vacuum Assisted Closure device for healing enhancement | Device: VAC<br>* Vacuum Assisted Closure device<br>|
| Experimental: Conventional dressing<br>Unprocessed Honey, malysia glycerine and betadine ointment | Device: VAC<br>* Vacuum Assisted Closure device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital staying length | the difference in hospital stay length between patients with necrotizing fasciitis who received conventional management versus those treated with vacuum-assisted closure. A systematic review showed a significant difference between the two methods | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Required other stages of debridement | Comparison in the other stages of debridement required in both methods | Baseline | 
| Expected closure of the wound by secondary intention | The difference in expected time required for closure of the wound by secondary intention between patients with necrotizing fasciitis who received conventional management versus those treated with vacuum-assisted closure. | Baseline |