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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 abdominus myocutaneous (TRAM) / deep inferior epigastric perforator (DIEP) flap.
In this study we will be conducting a randomised trial to study the efficacy of TIGR as a preferred reconstruction mesh for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.
1. 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.
2. 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.
3. 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 randomised 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 2012
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
National University Hospital, Singapore
Not yet recruiting
National University Hospital, Singapore
Published on BioPortfolio: 2014-07-23T21:08:53-0400
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