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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

Eligibility

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 details
    Dehiscence Wound

NCT04899466

RedDress Ltd.

15 October 2025

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