Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
ConditionDehiscence Wound
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRedDress Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ActiGraft
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov