Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|