Actively Recruiting
A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Led by RedDress Ltd. · Updated on 2024-11-15
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of ActiGraft, a whole blood clot gel device, for women with abdominal surgical wound dehiscence who need secondary wound closure. This prospective, single-arm study involves 20 women and compares their results to a historical group of 20 matched patients treated previously. The goal is to assess wound healing and closure over a period of up to 4 weeks. Participants will receive a weekly application of ActiGraft for up to 4 weeks or until their wound fully heals, whichever occurs first. The study focuses on secondary wound closure after laparotomy, with specific criteria for wound age and condition. An historical matched control group will be used for comparison of closure times and healing outcomes. During the study, researchers will monitor wound healing progress through measures such as complete wound closure incidence at 4 weeks, wound area reduction at 2, 4, and 6 weeks, and the durability of closure up to 6 weeks after healing. Participants will be followed closely to collect data on wound healing times and compare outcomes against past patients. The total involvement includes weekly treatments and evaluations over approximately a month or until healing is complete.
CONDITIONS
Brief Title
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Female participants only
- Women who had a laparotomy within the past 3 weeks
- Surgical wound dehiscence requiring secondary closure
- Wound open for more than 24 hours but less than 6 days
- Open wound includes epidermis, dermis, and subcutaneous fat
- Ability to sign informed consent form
You will not qualify if you...
- Necrotizing fasciitis
- Fascial dehiscence
- Unable to withdraw required blood volume (up to 18 mL weekly)
- Known coagulation problems or abnormal platelet levels
- Receiving intravenous heparin
- Pregnancy
- Receiving or scheduled to receive systemic steroids (Prednisone >10mg/day or equivalent) within past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 weeks
Participants receive ActiGraft, a whole blood clot gel, for secondary closure of abdominal surgical wound dehiscence.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 1 location
1
Meir Medical Center
Kfar Saba, Israel
Actively Recruiting
Research Team
S
Sharon Sirota
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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