Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
RedDress Ltd.
20 participants
Aug 1, 2021
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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).
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Interventions
Whole blood clot (WBC) gel
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04899466