NCT01658163

Brief Summary

The investigators prospectively studied the results of wound closure after abdominoplasty with randomized use of PrineoTM and conventional suturing to assess the possible difference in outcome between these two methods.Follow-up visits to the outpatient clinic were scheduled at 2 weeks, 6 months and 12 months after surgery. A panel consisting of three plastic surgeons and three plastic surgery residents assessed the wound and scar appearance during the three follow-up visits.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
Last Updated

January 7, 2013

Status Verified

January 1, 2013

First QC Date

May 9, 2012

Last Update Submit

January 3, 2013

Conditions

Surgical Wound DehiscenceCutis LaxaWound of Skin

Keywords

abdominoplasty,skin closure, dressings

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may not qualify if:

  • current intake of systemic steroids
  • known HIV-positive or other immunocompromised status
  • known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
  • personal or family history of keloid or hypertrophic scar formation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound DehiscenceCutis Laxa

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Daryousch Parvizi, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

August 6, 2012

Study Start

June 1, 2009

Study Completion

September 1, 2011

Last Updated

January 7, 2013

Record last verified: 2013-01