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NOT YET RECRUITING
NCT02487134
NA

Trial of Routine Abdominal Wall Closure Versus Reinforcement With TIGR Matrix Onlay

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-01-01

Completion Date

2027-06-30

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

DEVICE

TIGR Matrix

Reinforcement of the suture line with resorbable mesh

DEVICE

Control

Closure of the abdomen with conventional technique

Locations (1)

Karolinska University Hospital, Center for Digestive Diseases

Stockholm, Sweden