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

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.
 
ClinicalTrials.gov Identifier: NCT01574378
Recruitment Status : Unknown
Verified April 2012 by Vladimir Grigoryants MD, Grigoryants Medical Corporation.
Recruitment status was:  Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
Vladimir Grigoryants MD, Grigoryants Medical Corporation

Study Description
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Brief Summary:
VLock suture studied in abdominal wound closure. Time and cosmesis was studied

Condition or disease Intervention/treatment Phase
Open Surgical Wounds Device: conventional closure Device: V-Loc 90 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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.
Study Start Date : August 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

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Arms and Interventions
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Arm Intervention/treatment
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


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


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

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


Eligibility Criteria
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Ages Eligible for Study:   32 Years to 75 Years   (Adult, Older Adult)
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
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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
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United States, California
Vladimir Grigoryants, MD
Glendale, California, United States, 91206
Sponsors and Collaborators
Vladimir Grigoryants MD
More Information
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Responsible Party: Vladimir Grigoryants MD, sponsor investigator, Grigoryants Medical Corporation
ClinicalTrials.gov Identifier: NCT01574378    
Other Study ID Numbers: vl12345
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by Vladimir Grigoryants MD, Grigoryants Medical Corporation:
Abdominoplasty
Additional relevant MeSH terms:
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Wounds and Injuries
Surgical Wound