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TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136603
First Posted: June 3, 2010
Last Update Posted: January 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National University Hospital, Singapore
  Purpose
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.

Condition Intervention Phase
Hernia Device: TIGR Mesh Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Abdominal Wall Closure After TRAM / DIEP Flap - Comparison of TIGR Mesh vs Polypropylene Mesh.

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Shrinkage profiles of the implant [ Time Frame: 1 year ]
    Assess the shrinkage profiles of the implant after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months


Secondary Outcome Measures:
  • Amount of tissue ingrowth [ Time Frame: 1 year ]
    Assess the amount of tissue ingrowth after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months


Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136603


Contacts
Contact: Thiam Chye Lim, MD 67722022 surlimtc@nus.edu.sg
Contact: Eileen Hing 67722276 surhch@nus.edu.sg

Locations
Singapore
National University Hospital, Singapore Recruiting
Singapore, Singapore, 119074
Contact: Thiam Chye Lim, FRCS    67722022    surlimtc@nus.edu.sg   
Contact: Eileen Hing    67722276    surhch@nus.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Thiam Chye Lim, MD National University Hospital, Singapore
  More Information

Responsible Party: LIM THIAM CHYE / Professor, National University Hospital / National Unviersity of Singapore
ClinicalTrials.gov Identifier: NCT01136603     History of Changes
Other Study ID Numbers: NUHS/SUR-PRAS/2010/2
D / 10 / 344 ( Registry Identifier: DSRB: D/ 10 / 344 )
First Submitted: June 2, 2010
First Posted: June 3, 2010
Last Update Posted: January 28, 2014
Last Verified: January 2014

Keywords provided by National University Hospital, Singapore:
Abdominal wall defects
Inflammation reactions
Amount of tissue ingrowth
Adhesion formation
Shrinkage profiles of the implant