- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05883033
VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis
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 Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mario Saba, BMMS
- Phone Number: +201091196224
- Email: mario_saba_417@yahoo.com
Study Contact Backup
- Name: Abdullah Badawi, PhD
- Phone Number: +201001861127
- Email: abdallah.mersal@med.au.edu.eg
Study Locations
-
-
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Assiut, Egypt
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vacuum Assisted Closure device
Vacuum Assisted Closure device for healing enhancement
|
Vacuum Assisted Closure device
|
Experimental: Conventional dressing
Unprocessed Honey, malysia glycerine and betadine ointment
|
Vacuum Assisted Closure device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital staying length
Time Frame: 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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Required other stages of debridement
Time Frame: Baseline
|
Comparison in the other stages of debridement required in both methods
|
Baseline
|
Expected closure of the wound by secondary intention
Time Frame: 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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Necrotizing fasciitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Necrotizing Fascitis
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Dow University of Health SciencesCompleted
-
University Hospital, GhentResearch Foundation FlandersCompletedBurns | Necrotizing Fascitis | Full Thickness BurnBelgium
-
Ole HyldegaardSeventh Framework ProgrammeCompletedPrognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study (ProTreat)Fournier Gangrene | Necrotizing Soft Tissue Infection | Gas Gangrene | Necrotizing FascitisDenmark
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Tehran University of Medical SciencesCompletedNecrotizing FasciitisIran, Islamic Republic of
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Hospices Civils de LyonUnknownCervical Necrotizing FasciitisFrance
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Gorm GreisenCompletedComplications | NEC - Necrotizing EnterocolitisDenmark
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Mednax Center for Research, Education, Quality...Phoenix Children's Hospital; Banner University Medical CenterCompletedTotal Parenteral Nutrition | Necrotizing Enterocolitis of NewbornUnited States
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-
Asian Institute of Gastroenterology, IndiaCompletedAcute Pancreatitis NecrotizingIndia
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