Skin Laxity of Abdomen, Thighs, Chest, Back, and NeckPhase 4NCT00223132
Suture Granuloma in Body Contouring Surgery
A Phase 4 study testing Absorbable sutures in people with Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck, run by Medtronic - MITG at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck
- What is being tested?
- Absorbable sutures
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Apr 2007
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 years and older
Who cannot join
- Subjects with active infectious collagen disease,significant anatomic asymmetry that creates markedly different wound tension and/or geometry between left and right side Subjects who cancel their surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
About this study
The purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma.
Read the detailed description
Bariatric surgery has evolved as an effective treatment for morbid obesity, inducing rapid and predictable weight loss within a period of 12 to 18 months following surgery. Consequently, body contouring after weight loss is emerging as the fastest growing field of plastic surgery. Patients seek consultation with a plastic surgeon to correct skin laxity of the abdomen, thighs, chest, back, and neck.
A major problem in body contourinig is the extrusion of absorbable suture material used for dermal closure. Long incisions and high tension inherent to body contouring surgery mandate a secure dermal closure. While absorbable sutures are preferred, they can result in suture granuloma and extrusion.
- Being tested
- Absorbable sutures
- Keywords
- bariatric surgery, body contouring, skin laxity, plastic surgery, suture granuloma, absorbable sutures
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable suturesDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Laxity of Abdomen, Thighs, Chest, Back, and NeckStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Donna Doran, Study director, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223132
- Sponsor's protocol ID
- SYN04002
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2005
- Last updated
- 25 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture Granuloma in Body Contouring Surgery
- ClinicalTrials.gov ID
- NCT00223132
- Acronym / sponsor ID
- SYN04002
- Keywords
- bariatric surgery, body contouring, skin laxity, plastic surgery, suture granuloma, absorbable sutures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 22 Sep 2005 (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.
The purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma.
Detailed description
Bariatric surgery has evolved as an effective treatment for morbid obesity, inducing rapid and predictable weight loss within a period of 12 to 18 months following surgery. Consequently, body contouring after weight loss is emerging as the fastest growing field of plastic surgery. Patients seek consultation with a plastic surgeon to correct skin laxity of the abdomen, thighs, chest, back, and neck.
A major problem in body contourinig is the extrusion of absorbable suture material used for dermal closure. Long incisions and high tension inherent to body contouring surgery mandate a secure dermal closure. While absorbable sutures are preferred, they can result in suture granuloma and extrusion.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women 18 years and older
Key exclusion criteria (1 listed)
- Subjects with active infectious collagen disease,significant anatomic asymmetry that creates markedly different wound tension and/or geometry between left and right side Subjects who cancel their surgery
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 |
|---|---|---|
| Absorbable sutures | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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.
Donna Doran study director
Medtronic - MITG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Absorbable sutures in people with Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck, run by Medtronic - MITG at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Oct 2012. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 25 Oct 2012.