Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
|ClinicalTrials.gov Identifier: NCT01413412|
Recruitment Status : Unknown
Verified September 2015 by Leonard Clay, Karolinska Institutet.
Recruitment status was: Active, not recruiting
First Posted : August 10, 2011
Last Update Posted : September 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ventral Hernia Postoperative Pain||Procedure: Ventral hernia repair using full thickness skin graft Procedure: Ventral hernia repair using mesh||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Hernia repair using full-thickness skin graft
Procedure: Ventral hernia repair using full thickness skin graft
Experimental: Hernia repair using Mesh
Procedure: Ventral hernia repair using mesh
- Rate of complication [ Time Frame: 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.
- Ventral Hernia Pain Questionnaire (VHPQ) [ Time Frame: 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 [ Time Frame: 3 year period of follow up ]All subjects will undergo testing of abdominal wall function and strength using the Biodex.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413412
|Karolinska University Hospital|
|Study Director:||Karin Strigård, MD||Karolinska Institute CLINTEC|
|Principal Investigator:||Leonard Clay, MD||Karolinska Institute CLINTEC|
|Study Chair:||Ulf Gunnarsson, MD||Karolinska Institute CLINTEC|