Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
1 other identifier
interventional
50
1 country
1
Brief Summary
This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedSeptember 29, 2015
September 1, 2015
7 years
August 9, 2011
September 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 month, 1 year and 3 year post-operative clinical follow-up
Secondary Outcomes (2)
Ventral Hernia Pain Questionnaire (VHPQ)
1 year period of follow-up
Abdominal wall function
3 year period of follow up
Study Arms (2)
Hernia repair using full-thickness skin graft
EXPERIMENTAL25 patients
Hernia repair using Mesh
EXPERIMENTAL25 patients
Interventions
25 patients
Eligibility Criteria
You may qualify if:
- ventral hernia \> 10 centimeters, abdominal wall pain or discomfort, desire hernia repair.
You may not qualify if:
- \< 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital
Stockholm, Sweden
Related Publications (2)
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.
PMID: 34905143DERIVEDClay 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.
PMID: 29247365DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karin Strigård, MD
Karolinska Institute CLINTEC
- PRINCIPAL INVESTIGATOR
Leonard Clay, MD
Karolinska Institute CLINTEC
- STUDY CHAIR
Ulf Gunnarsson, MD
Karolinska Institute CLINTEC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 10, 2011
Study Start
December 1, 2009
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
September 29, 2015
Record last verified: 2015-09