Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Leonard Clay, Karolinska Institutet Identifier:
First received: August 9, 2011
Last updated: August 22, 2014
Last verified: August 2014

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

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study

Resource links provided by NLM:

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Rate of complication [ Time Frame: 3 month, 1 year and 3 year post-operative clinical follow-up ] [ Designated as safety issue: No ]
    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:
  • Ventral Hernia Pain Questionnaire (VHPQ) [ Time Frame: 1 year period of follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    All subjects will undergo testing of abdominal wall function and strength using the Biodex.

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hernia repair using full-thickness skin graft
25 patients will undergo hernia repair using autologous full-thickness skin graft
Procedure: Ventral hernia repair using full thickness skin graft
25 patients will undergo ventral hernia repair using a autologous onlay full thickness skin graft.
Experimental: Hernia repair using Mesh
25 patients will undergo ventral hernia repair using synthetic mesh.
Procedure: Ventral hernia repair using mesh
25 patients will undergo ventral hernia repair / abdominal wall reconstruction 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.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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

No publications provided

Responsible Party: Leonard Clay, Doctor, Karolinska Institutet Identifier: NCT01413412     History of Changes
Other Study ID Numbers: 2009/227-31/3
Study First Received: August 9, 2011
Last Updated: August 22, 2014
Health Authority: Sweden: Stockholms läns landsting

Keywords provided by Karolinska Institutet:
Ventral Hernia
Postoperative Pain
Ventral Hernia Pain Questionnaire
Postoperative Abdominal wall and muscle function

Additional relevant MeSH terms:
Pain, Postoperative
Pathologic Processes
Pathological Conditions, Anatomical
Postoperative Complications
Signs and Symptoms processed this record on March 03, 2015