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 range18 Years
SexALL
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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
What they're measuring
1
Number of patients with incisional hernia one year after surgery