Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence

Not Applicable

Recruiting

• Conditions: Dehiscence Wound

• Registration Number: NCT04899466
• Lead Sponsor: RedDress Ltd.

Brief Summary

This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure. The participants will receive a weekly application of ActiGraft for 4 weeks, or until complete healing of the wound (the earlier of the two).

An historic matched-control group of 20 patients will be compared retrospectively

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Study Start: 2021-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Age >18 years
• Women that had a laparotomy no more than 3 weeks before accrual.
• Surgical wound dehiscence that requires a secondary closure.
• Time from wound dehiscence >24 hours and <6 days.
• The open wound includes epidermis, dermis and sub cutaneous fat.
• The patient can sign an informed consent form.

Exclusion Criteria

• Patients with necrotizing fasciitis
• Patients with fascial dehiscence
• Cannot withdraw blood in the required amount (up to 18 mL per week).
• Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking oral anti-coagulants or anti-agreganrts will not be excluded.
• Pregnancy
• Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (Prednisone- more than 10mg/d or equivalent).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of complete wound closure	4 weeks	Skin re-epithelialization without drainage or dressing requirements

Secondary Outcome Measures

Name	Time	Method
Wound Percent Area Reduction (PAR)	2, 4 and 6 weeks	The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
Mean time of complete wound closure	4 weeks	Skin re-epithelialization without drainage or dressing requirements
Comparison of time to complete closure between study cases and historic control	4 weeks	Skin re-epithelialization without drainage or dressing requirements
Durability of wound closure 2 weeks after complete healing	Up to 6 weeks	No wound dehiscence

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel