NCT01136603

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

5 years

First QC Date

June 2, 2010

Last Update Submit

January 27, 2014

Conditions

Hernia

Keywords

Abdominal wall defectsInflammation reactionsAmount of tissue ingrowthAdhesion formationShrinkage profiles of the implant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Amount of tissue ingrowth

    1 year

Study Arms (2)

TIGR Mesh

EXPERIMENTAL

Experimental - TIGR Mesh

Device: TIGR Mesh

Control

ACTIVE COMPARATOR

Control group - Non absorbable Polypropylene mesh

Device: TIGR Mesh

Interventions

TIGR MeshDEVICE

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

Also known as: Experimental - TIGR Matrix Surgical Mesh, Control - Polypropylene mesh
ControlTIGR Mesh

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 - 80 years
  • Both Male, Female
  • all patients undergoing Lipectomy, TRAM / DIEP flap reconstruction
  • patients with abdominal wall defects

You may not qualify if:

  • patient refusal
  • infection of the abdominal / generalised infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital, Singapore

Singapore, Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Thiam Chye Lim, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thiam Chye Lim, MD

CONTACT

67722022surlimtc@nus.edu.sg

Eileen Hing

CONTACT

67722276surhch@nus.edu.sg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

SG(1)