Status:
RECRUITING
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Lead Sponsor:
RedDress Ltd.
Conditions:
Dehiscence Wound
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ActiGraf...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04899466
Start Date
August 1 2021
End Date
August 1 2026
Last Update
November 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Meir Medical Center
Kfar Saba, Israel