Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR) (NCT01083472) | Clinical Trial Compass
TerminatedPhase 4
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
Stopped: Surgical practice evolution changed acceptable standard of care and lead to potential enrollment bias.
France, Germany, Italy37 participantsStarted 2010-03
Plain-language summary
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adults (18years of age or older) who is able to provide written informed consent for study participation
* has need of surgical intervention for repair of (potentially) contaminated abdominal wall defect of \>3cm and \<22cm in length, where the viscera have not been exposed for more than 15 days in case of open abdomen(skin and fascia open).
* Is willing and able to return for all scheduled \& required study visit.
Exclusion Criteria: at the time of randomization
* severe systemic sepsis
* frank pus in the wound, a fistula that will not be closed at the time of surgery or intra-abdominal abscess in surgical area,
* ongoing necrotizing pancreatitis,
* Is on chronic immunosuppressive therapy, or other medication that influences wound healing
* requires only short-term temporary closure,
* requires a synthetic, non-absorbable mesh to close the abdominal wall defect
* is unable to undergo general anesthesia,
* has other major organ system dysfunction or disorder that would jeopardize subject completing the 24 month study.
* Is unable to undergo an MRI scan
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.