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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Grigoryants Medical Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Vladimir Grigoryants MD, Grigoryants Medical Corporation
ClinicalTrials.gov Identifier:
NCT01574378
First received: November 28, 2011
Last updated: April 8, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cost Effectiveness and Clinical Outcomes of Wound Closure Using V-Loc™ 90 Sutures.

Further study details as provided by Grigoryants Medical Corporation:

Primary Outcome Measures:
  • closure time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    operative closure time studied


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

  • Cosmesis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   32 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lipoabdominoplasty patients

Exclusion Criteria:

  • poor health,
  • history of radiation,
  • smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574378

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

No publications provided

Responsible Party: Vladimir Grigoryants MD, sponsor investigator, Grigoryants Medical Corporation
ClinicalTrials.gov Identifier: NCT01574378     History of Changes
Other Study ID Numbers: vl12345
Study First Received: November 28, 2011
Last Updated: April 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Grigoryants Medical Corporation:
Abdominoplasty

ClinicalTrials.gov processed this record on November 25, 2014