VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis

Not Applicable

Not yet recruiting

• Conditions: Necrotizing Fascitis
• Interventions: Device: VAC

• Registration Number: NCT05883033
• Lead Sponsor: Assiut University

Brief Summary

Find out the best management of Necrotizing Fasciitis after surgical debridement

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-04-22
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-28
• Last Update Submitted: 2023-05-28
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Study Start: 2023-06-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vacuum Assisted Closure device	VAC	Vacuum Assisted Closure device for healing enhancement
Conventional dressing	VAC	Unprocessed Honey, malysia glycerine and betadine ointment

Primary Outcome Measures

Name	Time	Method
Hospital staying length	Baseline	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

Secondary Outcome Measures

Name	Time	Method
Expected closure of the wound by secondary intention	Baseline	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.
Required other stages of debridement	Baseline	Comparison in the other stages of debridement required in both methods

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt