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

April 8, 2012 updated by: Vladimir Grigoryants MD

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Vladimir Grigoryants, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lipoabdominoplasty patients

Exclusion Criteria:

  • poor health,
  • history of radiation,
  • smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
closure time
Time Frame: 1 day
operative closure time studied
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety- number of complications
Time Frame: 12 months
Number of complications on control incisions vs number of complications on experimental incisions
12 months
Cosmesis
Time Frame: 12 months
Scar thickness and appearance
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vladimir Grigoryants MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

April 8, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

April 10, 2012

Last Update Submitted That Met QC Criteria

April 8, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vl12345

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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