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Effectiveness of Wound Closure Using V-Loc™ 90 Sutures in Lipoabdominoplasty Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Vladimir Grigoryants MD, Grigoryants Medical Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574378
First Posted: April 10, 2012
Last Update Posted: April 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vladimir Grigoryants MD, Grigoryants Medical Corporation
  Purpose
VLock suture studied in abdominal wound closure. Time and cosmesis was studied

Condition Intervention Phase
Open Surgical Wounds Device: conventional closure Device: V-Loc 90 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cost Effectiveness and Clinical Outcomes of Wound Closure Using V-Loc™ 90 Sutures.

Resource links provided by NLM:


Further study details as provided by Vladimir Grigoryants MD, Grigoryants Medical Corporation:

Primary Outcome Measures:
  • closure time [ Time Frame: 1 day ]
    operative closure time studied


Secondary Outcome Measures:
  • Safety- number of complications [ Time Frame: 12 months ]
    Number of complications on control incisions vs number of complications on experimental incisions

  • Cosmesis [ Time Frame: 12 months ]
    Scar thickness and appearance


Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control arm
Control arm- conventional method of wound closure
Device: conventional closure
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)
Experimental: V-Loc group
V-Loc 90 barbed sutures
Device: V-Loc 90
2-layer wound closure using V-Loc 90 barbed suture

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   32 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lipoabdominoplasty patients

Exclusion Criteria:

  • poor health,
  • history of radiation,
  • smoking
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574378


Locations
United States, California
Vladimir Grigoryants, MD
Glendale, California, United States, 91206
Sponsors and Collaborators
Vladimir Grigoryants MD
  More Information

Responsible Party: Vladimir Grigoryants MD, sponsor investigator, Grigoryants Medical Corporation
ClinicalTrials.gov Identifier: NCT01574378     History of Changes
Other Study ID Numbers: vl12345
First Submitted: November 28, 2011
First Posted: April 10, 2012
Last Update Posted: April 10, 2012
Last Verified: April 2012

Keywords provided by Vladimir Grigoryants MD, Grigoryants Medical Corporation:
Abdominoplasty

Additional relevant MeSH terms:
Wounds and Injuries


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