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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ActiGraft
DeviceWhole blood clot (WBC) gel
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: ActiGraftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of complete wound closure
Skin re-epithelialization without drainage or dressing requirements
Time frame
4 weeksSecondary outcomes
1
Wound Percent Area Reduction (PAR)
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
Time frame
2, 4 and 6 weeks2
Mean time of complete wound closure
Skin re-epithelialization without drainage or dressing requirements
Time frame
4 weeks3
Durability of wound closure 2 weeks after complete healing
No wound dehiscence
Time frame
Up to 6 weeks4
Comparison of time to complete closure between study cases and historic control
Skin re-epithelialization without drainage or dressing requirements
Time frame
4 weeksOther outcomes
1
Change in pain level
Measured by Numeric Rating Scale (0 - no pain at all to 10 - worst pain) weekly for 4 weeks post ActiGraft application
Time frame
1, 2, 3 and 4 weeks2
Patient satisfaction
Will be assessed by subject satisfaction survey using a 5-point Likert Scale (the higher score means a better outcome).
Time frame
1, 2, 3, 4, 6 weeks and 42 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov