VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05883033
Collaborator
(none)
30
1
2
11
2.7

Study Details

Study Description

Brief Summary

Find out the best management of Necrotizing Fasciitis after surgical debridement

Condition or Disease Intervention/Treatment Phase
  • Device: VAC
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparative Study Between Vacuum Assisted Closure (VAC) and Conventional Dressing in the Healing Process of Necrotizing Fasciitis After Surgical Debridement.. Clinical and Laboratory Study.
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vacuum Assisted Closure device

Vacuum Assisted Closure device for healing enhancement

Device: VAC
Vacuum Assisted Closure device

Experimental: Conventional dressing

Unprocessed Honey, malysia glycerine and betadine ointment

Device: VAC
Vacuum Assisted Closure device

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Required other stages of debridement [Baseline]

    Comparison in the other stages of debridement required in both methods

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mario Youhana Saba, Resident Dr, Assiut University
ClinicalTrials.gov Identifier:
NCT05883033
Other Study ID Numbers:
  • Necrotizing fasciitis
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2023