VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis

Necrotizing Fascitis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05883033
• Other study ID #: Necrotizing fasciitis
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: Mario Saba, BMMS
• Phone: +201091196224
• Email: mario_saba_417[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Find out the best management of Necrotizing Fasciitis after surgical debridement

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Necrotizing
• Necrotizing Fascitis

Intervention

Device:
• VAC
Vacuum Assisted Closure device

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Secondary	Required other stages of debridement	Comparison in the other stages of debridement required in both methods	Baseline
Secondary	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.	Baseline