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

NCT ID: NCT01413412

Last Updated: 2015-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ventral Hernia Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hernia repair using full-thickness skin graft

25 patients

Group Type EXPERIMENTAL

Ventral hernia repair using full thickness skin graft

Intervention Type PROCEDURE

25 patients

Hernia repair using Mesh

25 patients

Group Type EXPERIMENTAL

Ventral hernia repair using mesh

Intervention Type PROCEDURE

25 patients

Interventions

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Ventral hernia repair using full thickness skin graft

25 patients

Intervention Type PROCEDURE

Ventral hernia repair using mesh

25 patients

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Leonard Clay

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karin Strigård, MD

Role: STUDY_DIRECTOR

Karolinska Institute CLINTEC

Leonard Clay, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute CLINTEC

Ulf Gunnarsson, MD

Role: STUDY_CHAIR

Karolinska Institute CLINTEC

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 34905143 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29247365 (View on PubMed)

Other Identifiers

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2009/227-31/3

Identifier Type: -

Identifier Source: org_study_id

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