We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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.
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
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Ventral Hernia Postoperative Pain Procedure: Ventral hernia repair using full thickness skin graft Procedure: Ventral hernia repair using mesh

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.

Study Design

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
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01413412

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

Responsible Party: Leonard Clay, Doctor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01413412     History of Changes
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:
Pain, Postoperative
Hernia, Ventral
Incisional Hernia
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pathological Conditions, Anatomical
Hernia, Abdominal