TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial

National University Health System (NUHS)

Status and phase: Unknown; Phase 2

Conditions: Hernia

Treatments: Device: TIGR Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT01136603

D / 10 / 344 (Registry Identifier)

NUHS/SUR-PRAS/2010/2

Details and patient eligibility

About

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.

Full description

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 -

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 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

TIGR Mesh

Experimental group

Description:

Experimental - TIGR Mesh

Treatment:

Device: TIGR Mesh

Control

Active Comparator group

Description:

Control group - Non absorbable Polypropylene mesh

Treatment:

Device: TIGR Mesh