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

Recruiting now · Not applicable

Conditions studied: Dehiscence Wound

In brief

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

Key facts

Study ID

NCT04899466

Run by

RedDress Ltd.

People needed

20

Starts

2021-08-01

Expected to finish

2026-08-01

Last updated by the study team

2024-11-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Meir Medical Center — Kfar Saba, Israel (enrolling)

Full record on ClinicalTrials.gov

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