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

Tracking Information
First Received Date ^ICMJE	November 28, 2011
Last Updated Date	April 8, 2012
Start Date ^ICMJE	August 2010
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 8, 2012)	closure time [ Time Frame: 1 day ] [ Designated as safety issue: No ] operative closure time studied
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01574378 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 8, 2012)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effectiveness of Wound Closure Using V-Loc™ 90 Sutures in Lipoabdominoplasty Patients
Official Title ^ICMJE	Cost Effectiveness and Clinical Outcomes of Wound Closure Using V-Loc™ 90 Sutures.
Brief Summary	VLock suture studied in abdominal wound closure. Time and cosmesis was studied
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Open Surgical Wounds
Intervention ^ICMJE	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) Device: V-Loc 90 2-layer wound closure using V-Loc 90 barbed suture
Study Arm (s)	Active Comparator: Control arm Control arm- conventional method of wound closure Intervention: Device: conventional closure Experimental: V-Loc group V-Loc 90 barbed sutures Intervention: Device: V-Loc 90
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	30
Estimated Completion Date	October 2012
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: lipoabdominoplasty patients Exclusion Criteria: poor health, history of radiation, smoking
Gender	Both
Ages	32 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01574378
Other Study ID Numbers ^ICMJE	vl12345
Has Data Monitoring Committee	No
Responsible Party	Vladimir Grigoryants MD, Grigoryants Medical Corporation
Study Sponsor ^ICMJE	Vladimir Grigoryants MD
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Grigoryants Medical Corporation
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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