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

September 28, 2015 updated by: Leonard Clay, Karolinska Institutet

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 month, 1 year and 3 year post-operative clinical follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year period of follow-up
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.
3 year period of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/227-31/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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