Breast PtosisNCT00959374
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
A study testing V-Loc 180/90 Wound Closure Device and 3-0 Monocryl Absorbable Sutures in people with Breast Ptosis and Obesity, run by Medtronic - MITG at 8 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Ptosis, Obesity
- What is being tested?
- V-Loc 180/90 Wound Closure Device and 3-0 Monocryl Absorbable Sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 2009to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be 18 years of age or older.
- Subject must be in good overall health.
- Subject must be scheduled for individual or combined abdominoplasty, reduction mammaplasty, or mastopexy, other than concentric mastopexy, crescent mastopexy, or mastopexy with implants.
- Subject must be willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent.
Who cannot join
- Subject is pregnant or breast-feeding.
- Subject has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing.
- Subject has significant anatomic asymmetry that creates markedly different wound tension and/or geometry between the right and left side.
- Subject is allergic to the test suture made of glycolide and trimethylene carbonate or the control suture made of glycolide and epsilon-caprolactone.
- Subject has a BMI ≥ 40.
- Subject has diabetes requiring medication for glycemic control.
Show all 15Show fewer
- Subject has a fever (temperature > 38ºC), active skin infection or systemic infection at the time of surgery.
- Subject underwent chemotherapy or radiation within the last 6 months.
- Subject has a history of keloid or hypertrophic scar formation or other dermatologic conditions known to impair wound healing.
- Subject has a history of alcohol or drug abuse within 6 months prior to screening.
- Subject has a history of immunosuppressive drug use, including steroids, within the last 6 months.
- Subject has had a documented breast imaging finding or physical breast exam finding requiring further evaluation prior to elective surgery.
- Subject has not had a mammogram within the last 12 months, for female patients ≥ 40 years of age scheduled for mastopexy or reduction mammaplasty.
- Subject is taking part in another clinical study which directly relates to this study. If, however, the subject is taking part in a non-related study, the investigator should contact the Study Manager for advice.
- The investigator determines that the subject should not be included in the study for reasons not already specified.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Albany Medical Center
Albany, New York, 12206
Northwestern University
Chicago, Illinois, 60611
The Hunstad Center for Cosmetic Plastic Surgery
Huntersville, North Carolina, 28078
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
University of Rochester
Rochester, New York, 14642
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
Germany2 sites
Marien Hospital Stuttgart
Boheimstrasse, Stuttgart, 70199
University Hospital Bonn
Frauenklinik, Bonn, 53127
About this study
Official title: A Prospective, Randomized Study to Evaluate Dermal Closure With an Absorbable Barbed Suture (V-Loc 180 Absorbable Wound Closure Device or V-Loc 90 Absorbable Wound Closure Device) as Compared to a Conventional Absorbable Suture
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
Read the detailed description
One of the greater common challenges of a surgical procedure is to effectively and efficiently close wounds across various levels of muscle, fat, fascia and/or skin.
Surgical sutures continue to be the material of choice for wound closure. However, complications of sutures are those associated with tying knots to secure the suture. Examples of associated suture complications, although not comprehensive, include knot breakage and slippage, suture extrusion or spitting, infection, ischemia and scarring, reduced wound strength and inflammation and dehiscence.
Both interrupted and continuous suture patterns require knots for suture line security when conventional suture constructs are used. Barbed sutures are designed to eliminate the need for tying knots during closure, thus ameliorating the detrimental aspects of knots.
- Conditions
- Breast Ptosis, Obesity
- Being tested
- V-Loc 180/90 Wound Closure Device, 3-0 Monocryl Absorbable Sutures
- Keywords
- Abdominoplasty, Reduction Mammaplasty, Mastopexy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-Loc 180/90 Wound Closure DeviceDevice
Barbed absorbable suture
3-0 Monocryl Absorbable SuturesDevice
3-0 Monocryl Absorbable Suture (non-barbed)
| Study group | Role | What they receive |
|---|---|---|
| V-loc and Monocryl | Active comparator | Subjects served as their own control, and they were randomized to receive an intervention of a standard closure using 3-0 Monocryl™ on one side of the body and the test closure device, V-Loc 180/90, on the other side. The standard closure technique was agreed on by study investigators for control side, and included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl™ sutures, spaced no further than 2 cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl™ sutures. The test closure side, closure of the deep dermal layer was optional. If deep dermal sutures were used, interrupted 3-0 Monocryl™ sutures were required to be placed no closer than 5 cm apart followed by closure of the intradermal layer with test device, V-Loc 180/90. Receives: Device: V-Loc 180/90 Wound Closure Device; Device: 3-0 Monocryl Absorbable Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Dermal Closure Time
In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.
Measured: At time of surgery
Secondary outcomes (1)
Cosmesis
Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast PtosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Rubin, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959374
- Sponsor's protocol ID
- SYN08003
- Status last verified
- Mar 2013
- First submitted
- 13 Aug 2009
- Last updated
- 17 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study to Evaluate Dermal Closure With an Absorbable Barbed Suture (V-Loc 180 Absorbable Wound Closure Device or V-Loc 90 Absorbable Wound Closure Device) as Compared to a Conventional Absorbable Suture
- ClinicalTrials.gov ID
- NCT00959374
- Acronym / sponsor ID
- SYN08003
- Conditions
- Breast Ptosis, Obesity
- Keywords
- Abdominoplasty, Reduction Mammaplasty, Mastopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Posted 17 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
Detailed description
One of the greater common challenges of a surgical procedure is to effectively and efficiently close wounds across various levels of muscle, fat, fascia and/or skin.
Surgical sutures continue to be the material of choice for wound closure. However, complications of sutures are those associated with tying knots to secure the suture. Examples of associated suture complications, although not comprehensive, include knot breakage and slippage, suture extrusion or spitting, infection, ischemia and scarring, reduced wound strength and inflammation and dehiscence.
Both interrupted and continuous suture patterns require knots for suture line security when conventional suture constructs are used. Barbed sutures are designed to eliminate the need for tying knots during closure, thus ameliorating the detrimental aspects of knots.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V-loc and Monocryl | Active comparator | Device: V-Loc 180/90 Wound Closure Device, Device: 3-0 Monocryl Absorbable SuturesSubjects served as their own control, and they were randomized to receive an intervention of a standard closure using 3-0 Monocryl™ on one side of the body and the test closure device, V-Loc 180/90, on the other side. The standard closure technique was agreed on by study investigators for control side, and included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl™ sutures, spaced no further than 2 cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl™ sutures. The test closure side, closure of the deep dermal layer was optional. If deep dermal sutures were used, interrupted 3-0 Monocryl™ sutures were required to be placed no closer than 5 cm apart followed by closure of the intradermal layer with test device, V-Loc 180/90. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be 18 years of age or older.
- Subject must be in good overall health.
- Subject must be scheduled for individual or combined abdominoplasty, reduction mammaplasty, or mastopexy, other than concentric mastopexy, crescent mastopexy, or mastopexy with implants.
- Subject must be willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent.
Key exclusion criteria (15 listed)
- Subject is pregnant or breast-feeding.
- Subject has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing.
- Subject has significant anatomic asymmetry that creates markedly different wound tension and/or geometry between the right and left side.
- Subject is allergic to the test suture made of glycolide and trimethylene carbonate or the control suture made of glycolide and epsilon-caprolactone.
- Subject has a BMI ≥ 40.
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 |
|---|---|---|
| V-Loc 180/90 Wound Closure DeviceBarbed absorbable suture | Device | V-loc and Monocryl |
| 3-0 Monocryl Absorbable Sutures3-0 Monocryl Absorbable Suture (non-barbed) | Device | V-loc and Monocryl |
Primary outcome
Total Dermal Closure Time
Time frame: At time of surgery
In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.
1 secondary outcome
Cosmesis
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Rubin, MD principal investigator
University of Pittsburgh Medical Center
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-Loc 180/90 Wound Closure Device and 3-0 Monocryl Absorbable Sutures in people with Breast Ptosis and Obesity, run by Medtronic - MITG at 8 sites in 2 countries.
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 15 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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Total Dermal Closure Time (time frame: At time of surgery). 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 17 Apr 2013.