Actively Recruiting
Efficacy Evaluation 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
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Female patients who had a laparotomy within 3 weeks before joining the study
- Presence of surgical wound dehiscence requiring secondary closure
- Time since wound dehiscence between more than 24 hours and less than 6 days
- Open wound involving epidermis, dermis, and subcutaneous fat
- Ability to provide informed consent
You will not qualify if you...
- Presence of necrotizing fasciitis
- Presence of fascial dehiscence
- Unable to have blood drawn in the required amount (up to 18 mL per week)
- Known coagulation disorders, abnormal platelet levels, or receiving intravenous heparin
- Pregnancy
- Current or planned use of systemic steroids (Prednisone more than 10 mg/day or equivalent) within the past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Meir Medical Center
Kfar Saba, Israel
Actively Recruiting
Research Team
S
Sharon Sirota
CONTACT
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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