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

Primary Purpose

Ventral Hernia, Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Ventral hernia repair using full thickness skin graft
Ventral hernia repair using mesh
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring Ventral Hernia, Postoperative Pain, Ventral Hernia Pain Questionnaire, Postoperative Abdominal wall and muscle function, Biodex

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hernia repair using full-thickness skin graft

Hernia repair using Mesh

Arm Description

25 patients

25 patients

Outcomes

Primary Outcome Measures

Rate of complication
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)
All subjects will complete the VHPQ which will be used to assess their pre- and postoperative pain.
Abdominal wall function
All subjects will undergo testing of abdominal wall function and strength using the Biodex.

Full Information

First Posted
August 9, 2011
Last Updated
September 28, 2015
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01413412
Brief Title
Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
Official Title
Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Postoperative Pain
Keywords
Ventral Hernia, Postoperative Pain, Ventral Hernia Pain Questionnaire, Postoperative Abdominal wall and muscle function, Biodex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hernia repair using full-thickness skin graft
Arm Type
Experimental
Arm Description
25 patients
Arm Title
Hernia repair using Mesh
Arm Type
Experimental
Arm Description
25 patients
Intervention Type
Procedure
Intervention Name(s)
Ventral hernia repair using full thickness skin graft
Intervention Description
25 patients
Intervention Type
Procedure
Intervention Name(s)
Ventral hernia repair using mesh
Intervention Description
25 patients
Primary Outcome Measure Information:
Title
Rate of complication
Description
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.
Time Frame
3 month, 1 year and 3 year post-operative clinical follow-up
Secondary Outcome Measure Information:
Title
Ventral Hernia Pain Questionnaire (VHPQ)
Description
All subjects will complete the VHPQ which will be used to assess their pre- and postoperative pain.
Time Frame
1 year period of follow-up
Title
Abdominal wall function
Description
All subjects will undergo testing of abdominal wall function and strength using the Biodex.
Time Frame
3 year period of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Strigård, MD
Organizational Affiliation
Karolinska Institute CLINTEC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leonard Clay, MD
Organizational Affiliation
Karolinska Institute CLINTEC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulf Gunnarsson, MD
Organizational Affiliation
Karolinska Institute CLINTEC
Official's Role
Study Chair
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34905143
Citation
Holmdahl V, Stark B, Clay L, Gunnarsson U, Strigard K. Long-term follow-up of full-thickness skin grafting in giant incisional hernia repair: a randomised controlled trial. Hernia. 2022 Apr;26(2):473-479. doi: 10.1007/s10029-021-02544-z. Epub 2021 Dec 14.
Results Reference
derived
PubMed Identifier
29247365
Citation
Clay L, Stark B, Gunnarsson U, Strigard K. Full-thickness skin graft vs. synthetic mesh in the repair of giant incisional hernia: a randomized controlled multicenter study. Hernia. 2018 Apr;22(2):325-332. doi: 10.1007/s10029-017-1712-x. Epub 2017 Dec 15.
Results Reference
derived

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

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