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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

August 9, 2011
August 22, 2014
December 2009
December 2016   (final data collection date for primary outcome measure)
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.
Rate of complication [ Time Frame: 3 year period of 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.
Complete list of historical versions of study NCT01413412 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Ventral Hernia
  • Postoperative Pain
  • Procedure: Ventral hernia repair using full thickness skin graft
    25 patients will undergo ventral hernia repair using a autologous onlay full thickness skin graft.
  • Procedure: Ventral hernia repair using mesh
    25 patients will undergo ventral hernia repair / abdominal wall reconstruction using mesh.
  • Experimental: Hernia repair using full-thickness skin graft
    25 patients will undergo hernia repair using autologous full-thickness skin graft
    Intervention: Procedure: Ventral hernia repair using full thickness skin graft
  • Experimental: Hernia repair using Mesh
    25 patients will undergo ventral hernia repair using synthetic mesh.
    Intervention: Procedure: Ventral hernia repair using mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01413412
2009/227-31/3
No
Leonard Clay, Karolinska Institutet
Karolinska Institutet
Not Provided
Study Director: Karin Strigård, MD Karolinska Institute CLINTEC
Principal Investigator: Leonard Clay, MD Karolinska Institute CLINTEC
Study Chair: Ulf Gunnarsson, MD Karolinska Institute CLINTEC
Karolinska Institutet
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP