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Use of Prineo in Breast Reduction Surgery (Prineo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01996917
Recruitment Status : Completed
First Posted : November 27, 2013
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Christine Hsu Rohde, MD, Columbia University

Brief Summary:
This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with Prineo™. The treatment will be randomized to left or right breast. Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™ group, with each patient serving as her own control. For this study, the resident will close one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this study of incision closure under conditions as similar to normal conditions of closure.

Condition or disease Intervention/treatment Phase
Efficiency of Surgical Incision Closure Post-operative Scar Device: Prineo Not Applicable

Detailed Description:

Wound closure with dermal sutures is time consuming and may increase risk of infection and inflammation. Moreover, appearance of the resulting scar depends largely on surgeon technique. Use of the Prineo™ wound closure system may decrease operative time, decrease incidence of infection and inflammation, and improve aesthetics of the resulting scar. Prineo™ has been shown to hold as well as sutures for the first 12-25 days and may reduce closure time of the final skin layer up to 75% in abdominoplasty and breast procedures. The system provides excellent coverage of the wound edge, protecting the incision with a microbial barrier. Cosmetic results in abdominoplasty and breast procedures appear to be equivalent to sutures.

The main endpoints will be operative time to closure of the final skin layer and patient-rated and blinded observer-rated scar quality. The investigators hypothesize that operative time to closure of the final skin layer using Prineo™ will be faster than operative time to closure using subcuticular suture. The investigators also hypothesize that subjective and objective scar quality of incisions closed with Prineo™ will be better than those closed with subcuticular suture.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Prineo™ for Wound Closure in Breast Reduction Surgery
Actual Study Start Date : August 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Prineo closure
One breast will have skin closure with Prineo.
Device: Prineo
After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.
Other Name: Prineo wound closure system

No Intervention: Standard Suture
One breast will be closed in the standard fashion with suture.



Primary Outcome Measures :
  1. Operative Time to Closure of Final Skin Layer [ Time Frame: During operation only ]
    This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures.


Secondary Outcome Measures :
  1. Score on Patient Observer Scar Assessment Scale (POSAS) [ Time Frame: Up to 1 year ]
    The subject will complete the subjective part of the Patient Observer Scar Assessment Scale (POSAS) at each post-operative time point. Total score ranges from 6 to 60, with a higher score indicating a worse scar.


Other Outcome Measures:
  1. Score on the Vancouver Scar Scale (VSS) [ Time Frame: Up to 1 year ]
    A blinded plastic surgeon will evaluate objective scar quality using the Vancouver Scar Scale (VSS). Range of scores is from 0-13 with a higher score indicative of a worse scar.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing Wise pattern breast reductions for symptomatic macromastia.

Exclusion Criteria:

  • Subjects who have an allergy to cyanoacrylate, formaldehyde, surgical tape, or any other known component of the Prineo system will be excluded.
  • Subjects who refuse to be photographed or refuse to have their scars assessed by a blinded plastic surgeon will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996917


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10021
Sponsors and Collaborators
Columbia University
Ethicon, Inc.
Investigators
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Principal Investigator: Christine Rohde, MD,MPH Columbia University
Publications:
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Responsible Party: Christine Hsu Rohde, MD, Assistant Professor of Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT01996917    
Other Study ID Numbers: AAAM2053
First Posted: November 27, 2013    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019
Keywords provided by Christine Hsu Rohde, MD, Columbia University:
wound closure
prineo
scar
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries