TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial

Study Overview
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Brief Summary
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Hypothesis: TIGR mesh as a reconstruction material is a more effective mesh for the repair of the abdominal wall post lipectomy, transverse rectus abdominis myocutaneous (TRAM) / deep inferior epigastric perforator (DIEP) flap.

Detailed Description
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In this study we will be conducting a randomized trial to study the efficacy of TIGR as a preferred reconstruction mesh for the repair of the abdominal wall post lipectomy, TRAM / DIEP flap. Aims - Investigating the efficacy of TIGR as a preferred reconstruction mesh for the repair of the abdominal wall post lipectomy, TRAM / DIEP flap. Efficacy of TIGR will allow us to determine the stability of the material in the abdominal wall reconstruction. Study the absorption characteristics of TIGR implant as compared with a non absorbable polypropylene mesh. Absorption characteristics can be determined by the amount of tissue ingrowth, adhesion formation and shrinkage profiles of the implant and it can be detect using ultrasound. To determine whether any reactions to the implant will occur. These reaction if any will manifest as inflammation reactions which may be evident on clinical followup and can be detect by ultrasound. Patients to be recruited : 80 randomized equally into the 2 groups Age range: 21 - 80 All patients undergoing lipectomy, TRAM / DIEP flap reconstruction will be recruited into the study. Trial Duration: July 2010 - July 2015 Follow up: Postoperative 1 week, 1 month, 3 months, 6 months, and 12 months Ultrasound will be done to determine the amount of tissue ingrowth, adhesion formation and shrinkage profiles of the implant in all these follow up appointments. Complications if any can also be detected by the Ultrasound.

Official Title
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Abdominal Wall Closure After TRAM / DIEP Flap - Comparison of TIGR Mesh vs Polypropylene Mesh.

Conditions
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Hernia

Intervention / Treatment
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* Device: TIGR Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 - 80 years Both Male, Female all patients undergoing Lipectomy, TRAM / DIEP flap reconstruction patients with abdominal wall defects Exclusion Criteria: patient refusal infection of the abdominal / generalised infection

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIGR Mesh<br>Experimental - TIGR Mesh | Device: TIGR Mesh<br>* TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.<br>* Other names: Control - Polypropylene mesh;|
| Active Comparator: Control<br>Control group - Non absorbable Polypropylene mesh | Device: TIGR Mesh<br>* TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.<br>* Other names: Control - Polypropylene mesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shrinkage profiles of the implant | Assess the shrinkage profiles of the implant after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of tissue ingrowth | Assess the amount of tissue ingrowth after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal wall defects, Inflammation reactions, Amount of tissue ingrowth, Adhesion formation, Shrinkage profiles of the implant