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

NCT02487134 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-08-14

No results posted yet for this study

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.

Conditions

  • Open Wound of Abdominal Wall With Complication

Interventions

DEVICE

TIGR Matrix

Reinforcement of the suture line with resorbable mesh

DEVICE

Control

Closure of the abdomen with conventional technique

Sponsors & Collaborators

Principal Investigators

  • Gabriel Sandblom, Ass Prof · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02487134 on ClinicalTrials.gov