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

Karolinska Institutet50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ventral Hernia Postoperative Pain

Interventions

Ventral hernia repair using full thickness skin graftPROCEDURE

25 patients

Ventral hernia repair using meshPROCEDURE

25 patients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Karolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 3 month, 1 year and 3 year post-operative clinical follow-up

Secondary Outcomes

Ventral Hernia Pain Questionnaire (VHPQ)

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

Abdominal wall function

All subjects will undergo testing of abdominal wall function and strength using the Biodex.

Time frame: 3 year period of follow up

Data from ClinicalTrials.gov

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