Biological Meshes in Infected Fields: a Randomized Controlled Trial (NCT01594450) | Clinical Trial Compass
CompletedPhase 3
Biological Meshes in Infected Fields: a Randomized Controlled Trial
France110 participantsStarted 2012-05
Plain-language summary
The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.
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:
* wound infection related to a synthetic non-absorbable mesh for at least 15 days duration
* incisional abdominal hernia with an abcess or fistula, without the presence of a synthetic non-absorbable mesh
* incisional abdominal hernias smaller than 20 centimeter in the 2 largest diameters
* incisional abdominal hernias requiring a surgical procedure
* incisional abdominal hernias amenable to repair with a single biological mesh
* age over 18 years
Exclusion Criteria:
* non-infected incisional abdominal hernia
* history of biological mesh placement
* incisional abdominal hernia in contaminated, but non infected field (stoma presence, violation of gastrointestinal tract)
* incisional abdominal hernia larger than 20 x 20 cm
* BMI ≥ 40 kg/m2
* ASA score 4 and 5
* immunosuppression (including steroid and cytotoxic therapy)
* chronic disease such as cirrhosis, renal insufficiency with renal dialysis, malignant disease, known collagen disorder
* life expectancy under than 36 months
* allergy to one of the biological mesh components
* pregnancy or breastfeeding
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.