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

Postoperative Pain Clinical Trial

Official title:

Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01413412
• Other study ID #: 2009/227-31/3
• Status: Active, not recruiting
• Phase: N/A
• First received: August 9, 2011
• Last updated: September 28, 2015
• Start date: December 2009
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Stockholms läns landsting
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Pain, Postoperative
• Postoperative Pain
• Ventral Hernia

Intervention

Procedure:
• Ventral hernia repair using full thickness skin graft
25 patients
• Ventral hernia repair using mesh
25 patients

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Ventral Hernia Pain Questionnaire (VHPQ)	All subjects will complete the VHPQ which will be used to assess their pre- and postoperative pain.	1 year period of follow-up	No
Secondary	Abdominal wall function	All subjects will undergo testing of abdominal wall function and strength using the Biodex.	3 year period of follow up	No