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

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. 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
Information provided by (Responsible Party):
Leonard Clay, Karolinska Institutet

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Hernia repair using full-thickness skin graft
25 patients
Procedure: Ventral hernia repair using full thickness skin graft
25 patients

Experimental: Hernia repair using Mesh
25 patients
Procedure: Ventral hernia repair using mesh
25 patients

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01413412

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Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
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Study Director: Karin Strigård, MD Karolinska Institute CLINTEC
Principal Investigator: Leonard Clay, MD Karolinska Institute CLINTEC
Study Chair: Ulf Gunnarsson, MD Karolinska Institute CLINTEC

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Leonard Clay, Doctor, Karolinska Institutet Identifier: NCT01413412    
Other Study ID Numbers: 2009/227-31/3
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Keywords provided by Leonard Clay, Karolinska Institutet:
Ventral Hernia
Postoperative Pain
Ventral Hernia Pain Questionnaire
Postoperative Abdominal wall and muscle function
Additional relevant MeSH terms:
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Pain, Postoperative
Hernia, Ventral
Incisional Hernia
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical
Hernia, Abdominal