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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Leonard Clay, Karolinska Institutet.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01413412
First Posted: August 10, 2011
Last Update Posted: September 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Leonard Clay, Karolinska Institutet
August 9, 2011
August 10, 2011
September 29, 2015
December 2009
December 2016   (Final data collection date for primary outcome measure)
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.
Rate of complication [ Time Frame: 3 year period of 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.
Complete list of historical versions of study NCT01413412 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study
This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Ventral Hernia
  • Postoperative Pain
  • Procedure: Ventral hernia repair using full thickness skin graft
    25 patients
  • Procedure: Ventral hernia repair using mesh
    25 patients
  • Experimental: Hernia repair using full-thickness skin graft
    25 patients
    Intervention: Procedure: Ventral hernia repair using full thickness skin graft
  • Experimental: Hernia repair using Mesh
    25 patients
    Intervention: Procedure: Ventral hernia repair using mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
December 2016
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01413412
2009/227-31/3
No
Not Provided
Not Provided
Leonard Clay, Karolinska Institutet
Karolinska Institutet
Not Provided
Study Director: Karin Strigård, MD Karolinska Institute CLINTEC
Principal Investigator: Leonard Clay, MD Karolinska Institute CLINTEC
Study Chair: Ulf Gunnarsson, MD Karolinska Institute CLINTEC
Karolinska Institutet
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP