Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ActiGraft.
- Who it may be relevant to
- Registry conditions: Dehiscence Wound. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Overview
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
Interventions
- Device ActiGraft
Whole blood clot (WBC) gel
Primary outcome measures
- Incidence of complete wound closure [Time frame: 4 weeks]
Secondary outcome measures (4)
- Wound Percent Area Reduction (PAR) [Time frame: 2, 4 and 6 weeks]
- Mean time of complete wound closure [Time frame: 4 weeks]
- Durability of wound closure 2 weeks after complete healing [Time frame: Up to 6 weeks]
- Comparison of time to complete closure between study cases and historic control [Time frame: 4 weeks]
Eligibility 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.
- Time from wound dehiscence >24 hours and <6 days.
- The open wound includes epidermis, dermis and sub cutaneous fat.
- The patient can sign an informed consent form.
Exclusion criteria
- 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.
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Meir Medical Center — Kfar Saba
Identifiers
NCT: NCT04899466 · RD008