Back to resultsEffectiveness of Wound Closure Using V-Loc™ 90 Sutures in Lipoabdominoplasty Patients
Primary Purpose
Open Surgical Wounds
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
conventional closure
V-Loc 90
Sponsored by
About this trial
This is an interventional treatment trial for Open Surgical Wounds focused on measuring Abdominoplasty
Eligibility Criteria
Inclusion Criteria:
- lipoabdominoplasty patients
Exclusion Criteria:
- poor health,
- history of radiation,
- smoking
Sites / Locations
- Vladimir Grigoryants, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control arm
V-Loc group
Arm Description
Control arm- conventional method of wound closure
V-Loc 90 barbed sutures
Outcomes
Primary Outcome Measures
closure time
operative closure time studied
Secondary Outcome Measures
Safety- number of complications
Number of complications on control incisions vs number of complications on experimental incisions
Cosmesis
Scar thickness and appearance
Full Information
NCT ID
NCT01574378
First Posted
November 28, 2011
Last Updated
April 8, 2012
Sponsor
Vladimir Grigoryants MD
1. Study Identification
Unique Protocol Identification Number
NCT01574378
Brief Title
Effectiveness of Wound Closure Using V-Loc™ 90 Sutures in Lipoabdominoplasty Patients
Official Title
Cost Effectiveness and Clinical Outcomes of Wound Closure Using V-Loc™ 90 Sutures.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vladimir Grigoryants MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
VLock suture studied in abdominal wound closure. Time and cosmesis was studied
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Surgical Wounds
Keywords
Abdominoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Control arm- conventional method of wound closure
Arm Title
V-Loc group
Arm Type
Experimental
Arm Description
V-Loc 90 barbed sutures
Intervention Type
Device
Intervention Name(s)
conventional closure
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
V-Loc 90
Intervention Description
2-layer wound closure using V-Loc 90 barbed suture
Primary Outcome Measure Information:
Title
closure time
Description
operative closure time studied
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Safety- number of complications
Description
Number of complications on control incisions vs number of complications on experimental incisions
Time Frame
12 months
Title
Cosmesis
Description
Scar thickness and appearance
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lipoabdominoplasty patients
Exclusion Criteria:
poor health,
history of radiation,
smoking
Facility Information:
Facility Name
Vladimir Grigoryants, MD
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Wound Closure Using V-Loc™ 90 Sutures in Lipoabdominoplasty Patients
We'll reach out to this number within 24 hrs