HerniaPhase 2NCT01136603
TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial
A Phase 2 study testing TIGR Mesh in people with Hernia, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hernia
- What is being tested?
- TIGR Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2010to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 - 80 years
- Both Male, Female
- all patients undergoing Lipectomy, TRAM / DIEP flap reconstruction
- patients with abdominal wall defects
Who cannot join
- patient refusal
- infection of the abdominal / generalised infection
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital, Singapore
Singapore, Singapore, 119074
Thiam Chye Lim, FRCS, 67722022, surlimtc@nus.edu.sg
Eileen Hing, 67722276, surhch@nus.edu.sg
About this study
Official title: Abdominal Wall Closure After TRAM / DIEP Flap - Comparison of TIGR Mesh vs Polypropylene Mesh.
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.
Read the 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.
- Conditions
- Hernia
- Being tested
- TIGR Mesh
- Keywords
- Abdominal wall defects, Inflammation reactions, Amount of tissue ingrowth, Adhesion formation, Shrinkage profiles of the implant
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIGR MeshDevice
Also called Experimental - TIGR Matrix Surgical Mesh, Control - Polypropylene mesh
TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.
| Study group | Role | What they receive |
|---|---|---|
| TIGR Mesh | Experimental | Experimental - TIGR Mesh Receives: Device: TIGR Mesh |
| Control | Active comparator | Control group - Non absorbable Polypropylene mesh Receives: Device: TIGR Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Thiam Chye Lim, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136603
- Sponsor's protocol ID
- NUHS/SUR-PRAS/2010/2
- Other IDs
- D / 10 / 344
- Status last verified
- Jan 2014
- First submitted
- 2 Jun 2010
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Wall Closure After TRAM / DIEP Flap - Comparison of TIGR Mesh vs Polypropylene Mesh.
- ClinicalTrials.gov ID
- NCT01136603
- Acronym / sponsor ID
- NUHS/SUR-PRAS/2010/2
- Conditions
- Hernia
- Keywords
- Abdominal wall defects, Inflammation reactions, Amount of tissue ingrowth, Adhesion formation, Shrinkage profiles of the implant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIGR Mesh | Experimental | Device: TIGR MeshExperimental - TIGR Mesh |
| Control | Active comparator | Device: TIGR MeshControl group - Non absorbable Polypropylene mesh |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 - 80 years
- Both Male, Female
- all patients undergoing Lipectomy, TRAM / DIEP flap reconstruction
- patients with abdominal wall defects
Key exclusion criteria (2 listed)
- patient refusal
- infection of the abdominal / generalised infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIGR MeshAlso: Experimental - TIGR Matrix Surgical Mesh, Control - Polypropylene meshTIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap. | Device | Control, TIGR Mesh |
Primary outcome
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
1 secondary outcome
Amount of tissue ingrowth
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thiam Chye Lim, MD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TIGR Mesh in people with Hernia, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thiam Chye Lim, MD (67722022, surlimtc@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shrinkage profiles of the implant (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.