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

RedDress

Status

Enrolling

Conditions

Dehiscence Wound

Treatments

Device: ActiGraft

Study type

Interventional

Funder types

Industry

Identifiers

NCT04899466

RD008

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).