This trial is active, not recruiting.

Conditions ventral hernia, postoperative pain
Treatments ventral hernia repair using full thickness skin graft, ventral hernia repair using mesh
Sponsor Karolinska Institutet
Start date December 2009
End date December 2016
Trial size 50 participants
Trial identifier NCT01413412, 2009/227-31/3


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
25 patients
ventral hernia repair using full thickness skin graft
25 patients
25 patients
ventral hernia repair using mesh
25 patients

Primary Outcomes

Rate of complication
time frame: 3 month, 1 year and 3 year post-operative clinical follow-up

Secondary Outcomes

Ventral Hernia Pain Questionnaire (VHPQ)
time frame: 1 year period of follow-up
Abdominal wall function
time frame: 3 year period of follow up

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study
Principal investigator Leonard Clay, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Karolinska Institutet.