Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ActiGraft Whole blood clot (WBC) gel |
Device: ActiGraft
Whole blood clot (WBC) gel
|
Outcome Measures
Primary Outcome Measures
- Incidence of complete wound closure [4 weeks]
Skin re-epithelialization without drainage or dressing requirements
Secondary Outcome Measures
- Wound Percent Area Reduction (PAR) [2, 4 and 6 weeks]
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
- Mean time of complete wound closure [4 weeks]
Skin re-epithelialization without drainage or dressing requirements
- Durability of wound closure 2 weeks after complete healing [Up to 6 weeks]
No wound dehiscence
- Comparison of time to complete closure between study cases and historic control [4 weeks]
Skin re-epithelialization without drainage or dressing requirements
Other Outcome Measures
- Change in pain level [1, 2, 3 and 4 weeks]
Measured by Numeric Rating Scale (0 - no pain at all to 10 - worst pain) weekly for 4 weeks post ActiGraft application
- Patient satisfaction [1, 2, 3, 4, 6 weeks and 42 days]
Will be assessed by subject satisfaction survey using a 5-point Likert Scale (the higher score means a better outcome).
Eligibility Criteria
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.
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Time from wound dehiscence >24 hours and <6 days.
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The open wound includes epidermis, dermis and sub cutaneous fat.
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The patient can sign an informed consent form.
Exclusion Criteria:
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Patients with necrotizing fasciitis
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Patients with fascial dehiscence
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Cannot withdraw blood in the required amount (up to 18 mL per week).
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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.
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emek Medical Center | Afula | Israel |
Sponsors and Collaborators
- RedDress Ltd.
Investigators
- Study Director: Sharon Sirota, RedDress Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RD008