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TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial

2014-07-23 21:08:53 | BioPortfolio

Summary

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.

Description

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.

Aims -

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

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.

Study Design

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

Conditions

Hernia

Intervention

TIGR Mesh

Location

National University Hospital, Singapore
Singapore
Singapore
119074

Status

Not yet recruiting

Source

National University Hospital, Singapore

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:53-0400

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Medical and Biotech [MESH] Definitions

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Any woven or knit material of open texture used in surgery for the repair, reconstruction, or substitution of tissue. The mesh is usually a synthetic fabric made of various polymers. It is occasionally made of metal.

A pelvic hernia through the obturator foramen, a large aperture in the hip bone normally covered by a membrane. Obturator hernia can lead to intestinal incarceration and INTESTINAL OBSTRUCTION.

A groin hernia occurring inferior to the inguinal ligament and medial to the FEMORAL VEIN and FEMORAL ARTERY. The femoral hernia sac has a small neck but may enlarge considerably when it enters the subcutaneous tissue of the thigh. It is caused by defects in the ABDOMINAL WALL.

A hernia caused by weakness of the anterior ABDOMINAL WALL due to midline defects, previous incisions, or increased intra-abdominal pressure. Ventral hernias include UMBILICAL HERNIA, incisional, epigastric, and spigelian hernias.

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