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TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01136603
Enrollment
80
Registered
2010-06-03
Start date
2010-07-31
Completion date
2015-07-31
Last updated
2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia

Keywords

Abdominal wall defects, Inflammation reactions, Amount of tissue ingrowth, Adhesion formation, Shrinkage profiles of the implant

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 - 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.

Interventions

DEVICETIGR Mesh

TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Shrinkage profiles of the implant1 yearAssess the shrinkage profiles of the implant after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months

Secondary

MeasureTime frameDescription
Amount of tissue ingrowth1 yearAssess the amount of tissue ingrowth after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months

Countries

Singapore

Contacts

Primary ContactThiam Chye Lim, MD
surlimtc@nus.edu.sg67722022
Backup ContactEileen Hing
surhch@nus.edu.sg67722276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026