NCT05883033

Brief Summary

Find out the best management of Necrotizing Fasciitis after surgical debridement

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

April 22, 2023

Last Update Submit

May 28, 2023

Conditions

Necrotizing Fascitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Required other stages of debridement

    Baseline

  • Expected closure of the wound by secondary intention

    Baseline

Study Arms (2)

Vacuum Assisted Closure device

EXPERIMENTAL

Vacuum Assisted Closure device for healing enhancement

Device: VAC

Conventional dressing

EXPERIMENTAL

Unprocessed Honey, malysia glycerine and betadine ointment

Device: VAC

Interventions

VACDEVICE

Vacuum Assisted Closure device

Conventional dressingVacuum Assisted Closure device

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Immunocompromised patients such as; diabetic, HIV and leukaemia.
  • And other chronic debilitating diseases.

You may not qualify if:

  • Necrotizing Fasciitis of Head and neck and upper limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related 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.

    PMID: 36737764BACKGROUND

MeSH Terms

Conditions

Fasciitis, Necrotizing

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal Diseases

Central Study Contacts

Mario Saba, BMMS

CONTACT

+201091196224mario_saba_417@yahoo.com

Abdullah Badawi, PhD

CONTACT

+201001861127abdallah.mersal@med.au.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Dr

Study Record Dates

First Submitted

April 22, 2023

First Posted

May 31, 2023

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 30, 2024

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

EG(1)