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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Leonard Clay, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01413412
First received: August 9, 2011
Last updated: August 22, 2014
Last verified: August 2014
  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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Leonard Clay, Doctor, Karolinska Institutet
ClinicalTrials.gov 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
Biodex

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pain, Postoperative
Hernia, Abdominal
Pain
Pathologic Processes
Pathological Conditions, Anatomical
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014