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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
  Purpose
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
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

Resource links provided by NLM:


Further study details as provided by Leonard Clay, Karolinska Institutet:

Primary Outcome Measures:
  • 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:
  • 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.


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
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

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.
  Eligibility

Information from the National Library of Medicine

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

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


Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
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
  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 Submitted: August 9, 2011
First Posted: August 10, 2011
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
Biodex

Additional relevant MeSH terms:
Hernia
Pain, Postoperative
Hernia, Ventral
Incisional Hernia
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Hernia, Abdominal