Trial of Routine Abdominal Wall Closure Versus Reinforcement With TIGR Matrix Onlay (NCT02487134) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Trial of Routine Abdominal Wall Closure Versus Reinforcement With TIGR Matrix Onlay
Sweden200 participantsStarted 2026-01-01
Plain-language summary
Patients with at least two risk factors for incisional hernia undergoing abdominal surgery are eligible for inclusion. After accepting informed consent, patients are randomized into either closing the abdominal wall in a regular way with fascial sutures, or closing with fascial sutures together with placing a TIGR mesh as described. All patients are then monitored for signs of infection, wound rupture, incisional hernias, subcutaneous seroma as well as postoperative symptoms. All patients will be followed for at least 5 years. One year postoperatively, a computer scan is performed to detect asymptomatic incisional hernias.
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:
* Reoperation
* Age over 80 years
* Generalised malignant decease (presence of distant metastases at the time of surgery)
* COPD (Chronic obstructive pulmonary disease). Grade III-IV according to the GOLD classification (FEV1 \< 50% of the expected)
* Serum Albumin level \<20 g/l
* Sepsis. Infection in combination with two or more of the following: abnormal body temperature, heart rate, respiratory rate or blood gas, and white blood cell count.
* BMI 35-45 (for patients with BMI\>45, no additional risk factors are required for inclusion)
* Hemoglobin \<80 g/l
* Diabetes with secondary complications (angiopathia, nephropathia or neuropathia) and insulin treatment
* Steroid treatment (with at least 1 mg betamethasone daily or equivalent) for 7 days preoperatively
* Smoking (at least 10 cigarettes a day for one year)
* Chemotherapy (last administration within 2 weeks prior to surgery
* Radiation therapy of the abdominal wall
Exclusion Criteria:
* Presence of mesh after previous surgery
* Presence of incisional hernia
* Wound length \<10 cm
* Pregnancy
* Age \< 18 years
* Infected wounds
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.
What they're measuring
1
Number of patients with incisional hernia one year after surgery