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NCT Number: NCT01996917

Use of Prineo in Breast Reduction Surgery

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.

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Key information

Conditions

Efficiency of Surgical Incision Closure Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Scar

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prineo

Device

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 names: Prineo wound closure system

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Ethicon, Inc.

Registry information

Official study title

Use of Prineo™ for Wound Closure in Breast Reduction Surgery

Acronym: Prineo

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2013
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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