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VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis

NCT ID: NCT05883033

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-04-30

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.

Conditions

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Necrotizing Fascitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vacuum Assisted Closure device

Vacuum Assisted Closure device for healing enhancement

Group Type EXPERIMENTAL

VAC

Intervention Type DEVICE

Vacuum Assisted Closure device

Conventional dressing

Unprocessed Honey, malysia glycerine and betadine ointment

Group Type EXPERIMENTAL

VAC

Intervention Type DEVICE

Vacuum Assisted Closure device

Interventions

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VAC

Vacuum Assisted Closure device

Intervention Type DEVICE

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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mario Youhana Saba

Resident Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mario Saba, BMMS

Role: CONTACT

Phone: +201091196224

Email: [email protected]

Abdullah Badawi, PhD

Role: CONTACT

Phone: +201001861127

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 36737764 (View on PubMed)

Other Identifiers

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Necrotizing fasciitis

Identifier Type: -

Identifier Source: org_study_id