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

NCT02487134 | Not Yet Recruiting

• 1 other identifier: PrevMesh
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of patients with incisional hernia one year after surgery

  One year

Secondary Outcomes (3)

• Number of patients with wound dehiscence within one month after surgery

  One month

• Number of patients with persisting pain

  Five years

• Number of patients with seroma and infection

  One month

Study Arms (2)

Conventional abdominal wall closure

PLACEBO COMPARATOR

The aponeurosis is closed with continuous PDS 2/0 sutures, with self-locking anchor knots. The stitches are placed 5-8 mm from the wound edge, 4-5 mm apart.

Device: Control

Reinforcement with resorbable mesh

ACTIVE COMPARATOR

After closing the aponeurosis with PDS 2/0, a 7 cm wide TIGR Matrix Surgical Mesh is applied on the aponeurosis. The mesh is sutured to the aponeurosis with continuous PDS 2/0, with a wound to suture ratio of 1:4.

Device: TIGR Matrix

Interventions

TIGR Matrix DEVICE

Reinforcement of the suture line with resorbable mesh

Reinforcement with resorbable mesh

Control DEVICE

Closure of the abdomen with conventional technique

Conventional abdominal wall closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Presence of mesh after previous surgery
• Presence of incisional hernia
• Wound length \<10 cm
• Pregnancy
• Age \< 18 years
• Infected wounds

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital, Center for Digestive Diseases

Stockholm, 14186, Sweden

Location

Study Officials

• Gabriel Sandblom, Ass Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Sandblom, Ass Prof

CONTACT

+46704158218; gabriel.sandblom@ki.se

Per Hellman, Professor

CONTACT

+46709992199; per.hellman@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2015
• First Posted: July 1, 2015
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

SE (1)