TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial

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

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.

Study Overview

• Status: Unknown
• Conditions: Hernia
• Intervention / Treatment: Device: TIGR Mesh

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital, Singapore
    • Contact: Eileen Hing; Phone Number: 67722276; Email: surhch@nus.edu.sg
    • Contact: Thiam Chye Lim, FRCS; Phone Number: 67722022; Email: surlimtc@nus.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimate): June 3, 2010

Study Record Updates

• Last Update Posted (Estimate): January 28, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Abdominal wall defects; Inflammation reactions; Amount of tissue ingrowth; Adhesion formation; Shrinkage profiles of the implant
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: NUHS/SUR-PRAS/2010/2; D / 10 / 344 (Registry Identifier: DSRB: D/ 10 / 344)