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VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis

Primary Purpose

Necrotizing Fascitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
VAC
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotizing Fascitis

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vacuum Assisted Closure device

Conventional dressing

Arm Description

Vacuum Assisted Closure device for healing enhancement

Unprocessed Honey, malysia glycerine and betadine ointment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Required other stages of debridement
Comparison in the other stages of debridement required in both methods
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.

Full Information

First Posted
April 22, 2023
Last Updated
May 28, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05883033
Brief Title
VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Fascitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vacuum Assisted Closure device
Arm Type
Experimental
Arm Description
Vacuum Assisted Closure device for healing enhancement
Arm Title
Conventional dressing
Arm Type
Experimental
Arm Description
Unprocessed Honey, malysia glycerine and betadine ointment
Intervention Type
Device
Intervention Name(s)
VAC
Intervention Description
Vacuum Assisted Closure device
Primary Outcome Measure Information:
Title
Hospital staying length
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Required other stages of debridement
Description
Comparison in the other stages of debridement required in both methods
Time Frame
Baseline
Title
Expected closure of the wound by secondary intention
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Saba, BMMS
Phone
+201091196224
Email
mario_saba_417@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Badawi, PhD
Phone
+201001861127
Email
abdallah.mersal@med.au.edu.eg
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36737764
Citation
Zhang R, Zhang Y, Hou L, Yan C. Vacuum-assisted closure versus conventional dressing in necrotizing fasciitis: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Feb 4;18(1):85. doi: 10.1186/s13018-023-03561-7.
Results Reference
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VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis

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