TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial
Primary Purpose
Hernia
Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
TIGR Mesh
Sponsored by
About this trial
This is an interventional treatment trial for Hernia focused on measuring Abdominal wall defects, Inflammation reactions, Amount of tissue ingrowth, Adhesion formation, Shrinkage profiles of the implant
Eligibility 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
Sites / Locations
- National University Hospital, SingaporeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TIGR Mesh
Control
Arm Description
Experimental - TIGR Mesh
Control group - Non absorbable Polypropylene mesh
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01136603
First Posted
June 2, 2010
Last Updated
January 27, 2014
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT01136603
Brief Title
TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial
Official Title
Abdominal Wall Closure After TRAM / DIEP Flap - Comparison of TIGR Mesh vs Polypropylene Mesh.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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 -
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
Abdominal wall defects, Inflammation reactions, Amount of tissue ingrowth, Adhesion formation, Shrinkage profiles of the implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TIGR Mesh
Arm Type
Experimental
Arm Description
Experimental - TIGR Mesh
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control group - Non absorbable Polypropylene mesh
Intervention Type
Device
Intervention Name(s)
TIGR Mesh
Other Intervention Name(s)
Experimental - TIGR Matrix Surgical Mesh, Control - Polypropylene mesh
Intervention Description
TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.
Primary Outcome Measure Information:
Title
Shrinkage profiles of the implant
Description
Assess the shrinkage profiles of the implant after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Amount of tissue ingrowth
Description
Assess the amount of tissue ingrowth after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thiam Chye Lim, MD
Phone
67722022
Email
surlimtc@nus.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Hing
Phone
67722276
Email
surhch@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thiam Chye Lim, MD
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital, Singapore
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiam Chye Lim, FRCS
Phone
67722022
Email
surlimtc@nus.edu.sg
First Name & Middle Initial & Last Name & Degree
Eileen Hing
Phone
67722276
Email
surhch@nus.edu.sg
12. IPD Sharing Statement
Learn more about this trial
TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial
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