Open Surgical WoundsPhase 4NCT01574378
Effectiveness of Wound Closure Using V-Loc™ 90 Sutures in Lipoabdominoplasty Patients
A Phase 4 study testing conventional closure and V-Loc 90 in people with Open Surgical Wounds, run by Vladimir Grigoryants MD at 1 site in United States.
Trial summary
VLock suture studied in abdominal wound closure. Time and cosmesis was studied Read more about this study
- Who is it for?
- Ages 32 to 75 years
- Conditions the study is for
- Open Surgical Wounds
- What is being tested?
- conventional closure and V-Loc 90
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2012
- 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 32 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lipoabdominoplasty patients
Who cannot join
- poor health,
- history of radiation,
- smoking
Trial locations and contacts
1 site in 1 country.
United States1 site
Vladimir Grigoryants, MD
Glendale, California, 91206
About this study
Official title: Cost Effectiveness and Clinical Outcomes of Wound Closure Using V-Loc™ 90 Sutures.
VLock suture studied in abdominal wound closure. Time and cosmesis was studied
- Conditions
- Open Surgical Wounds
- Being tested
- conventional closure, V-Loc 90
- Keywords
- Abdominoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional closureDevice
non barbed sutures used to close wounds Conventional three layer wound closure using non-locking sutures polyglactin 910 (Vicryl, Ethicon) and polyglecaprone 25 (Monocryl, Ethicon)
V-Loc 90Device
2-layer wound closure using V-Loc 90 barbed suture
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Control arm- conventional method of wound closure Receives: Device: conventional closure |
| V-Loc group | Experimental | V-Loc 90 barbed sutures Receives: Device: V-Loc 90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
closure time
operative closure time studied
Measured: 1 day
Secondary outcomes (2)
Safety- number of complications
Number of complications on control incisions vs number of complications on experimental incisions
Measured: 12 months
Cosmesis
Scar thickness and appearance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startAug 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Surgical WoundsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vladimir Grigoryants MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vladimir Grigoryants MD, Grigoryants Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574378
- Sponsor's protocol ID
- vl12345
- Status last verified
- Apr 2012
- First submitted
- 28 Nov 2011
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness and Clinical Outcomes of Wound Closure Using V-Loc™ 90 Sutures.
- ClinicalTrials.gov ID
- NCT01574378
- Acronym / sponsor ID
- vl12345
- Conditions
- Open Surgical Wounds
- Keywords
- Abdominoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vladimir Grigoryants MDUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 10 Apr 2012 (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.
VLock suture studied in abdominal wound closure. Time and cosmesis was studied
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Device: conventional closureControl arm- conventional method of wound closure |
| V-Loc group | Experimental | Device: V-Loc 90V-Loc 90 barbed sutures |
Who may qualify
- Ages
- 32 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lipoabdominoplasty patients
Key exclusion criteria (3 listed)
- poor health,
- history of radiation,
- smoking
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 |
|---|---|---|
| conventional closurenon barbed sutures used to close wounds Conventional three layer wound closure using non-locking sutures polyglactin 910 (Vicryl, Ethicon) and polyglecaprone 25 (Monocryl, Ethicon) | Device | Control arm |
| V-Loc 902-layer wound closure using V-Loc 90 barbed suture | Device | V-Loc group |
Primary outcome
closure time
Time frame: 1 day
operative closure time studied
2 secondary outcomes
Safety- number of complications
Time frame: 12 months
Cosmesis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 conventional closure and V-Loc 90 in people with Open Surgical Wounds, run by Vladimir Grigoryants MD 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 3 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 10 Apr 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?
Results are not available in the source record.
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?
closure time (time frame: 1 day). 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 10 Apr 2012.