TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial
NCT ID: NCT01136603
Last Updated: 2014-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2010-07-31
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TIGR Mesh
Experimental - TIGR Mesh
TIGR Mesh
TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.
Control
Control group - Non absorbable Polypropylene mesh
TIGR Mesh
TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.
Interventions
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TIGR Mesh
TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both Male, Female
* all patients undergoing Lipectomy, TRAM / DIEP flap reconstruction
* patients with abdominal wall defects
Exclusion Criteria
* infection of the abdominal / generalised infection
21 Years
80 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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National University Hospital / National Unviersity of Singapore
Principal Investigators
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Thiam Chye Lim, MD
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital, Singapore
Singapore, Singapore, Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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D / 10 / 344
Identifier Type: REGISTRY
Identifier Source: secondary_id
NUHS/SUR-PRAS/2010/2
Identifier Type: -
Identifier Source: org_study_id
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