Text Size

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

This study is ongoing, but not recruiting participants.
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
History of Changes
  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
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 May 23, 2013