Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia

Not Applicable

• Conditions: Postoperative Pain; Ventral Hernia
• Interventions: Procedure: Ventral hernia repair using mesh; Procedure: Ventral hernia repair using full thickness skin graft

• Registration Number: NCT01413412
• Lead Sponsor: Karolinska Institutet

Brief Summary

This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.

Detailed Description

Patients with giant (\>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ventral hernia > 10 centimeters, abdominal wall pain or discomfort, desire hernia repair.

Exclusion Criteria

• < 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hernia repair using Mesh	Ventral hernia repair using mesh	25 patients
Hernia repair using full-thickness skin graft	Ventral hernia repair using full thickness skin graft	25 patients

Primary Outcome Measures

Name	Time	Method
Rate of complication	3 month, 1 year and 3 year post-operative clinical follow-up	Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation.

Secondary Outcome Measures

Name	Time	Method
Ventral Hernia Pain Questionnaire (VHPQ)	1 year period of follow-up	All subjects will complete the VHPQ which will be used to assess their pre- and postoperative pain.
Abdominal wall function	3 year period of follow up	All subjects will undergo testing of abdominal wall function and strength using the Biodex.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden