NCT01574378

Brief Summary

VLock suture studied in abdominal wound closure. Time and cosmesis was studied

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

2.2 years

First QC Date

November 28, 2011

Last Update Submit

April 8, 2012

Conditions

Open Surgical Wounds

Keywords

Abdominoplasty

Outcome Measures

Primary Outcomes (1)

  • closure time

    operative closure time studied

    1 day

Secondary Outcomes (2)

  • Safety- number of complications

    12 months

  • Cosmesis

    12 months

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Control arm- conventional method of wound closure

Device: conventional closure

V-Loc group

EXPERIMENTAL

V-Loc 90 barbed sutures

Device: V-Loc 90

Interventions

conventional closureDEVICE

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)

Control arm
V-Loc 90DEVICE

2-layer wound closure using V-Loc 90 barbed suture

V-Loc group

Eligibility Criteria

Age32 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lipoabdominoplasty patients

You may not qualify if:

  • poor health,
  • history of radiation,
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vladimir Grigoryants, MD

Glendale, California, 91206, United States

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
sponsor investigator

Study Record Dates

First Submitted

November 28, 2011

First Posted

April 10, 2012

Study Start

August 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

US(1)