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

Launched by REDDRESS LTD. · May 19, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness of a treatment called ActiGraft for women who have experienced a surgical wound dehiscence, which means their surgical wound has reopened after surgery. The study will involve 20 women who had a specific type of surgery called a laparotomy within the last three weeks and whose wounds need to be closed again. Participants will receive ActiGraft applied to their wounds once a week for up to four weeks or until the wound is fully healed.

To be eligible for this study, participants need to be over 18 years old, be women, and have a certain type of open wound that includes skin and underlying tissue. They should have had their wound open for more than a day but less than a week. However, women who are pregnant, have severe infections, or certain blood conditions will not be able to participate. Those who join the study can expect regular visits for treatment and monitoring of their wound healing progress. This trial aims to gather important information that could help improve care for women with similar surgical wounds in the future.

Gender

FEMALE

Eligibility criteria

• 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).