Use of Prineo in Breast Reduction Surgery

Not Applicable

Completed

• Conditions: Post-operative Scar; Efficiency of Surgical Incision Closure
• Interventions: Device: Prineo

• Registration Number: NCT01996917
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-27
• Study Start: 2014-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2019-03-22
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-18
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Women undergoing Wise pattern breast reductions for symptomatic macromastia.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prineo closure	Prineo	One breast will have skin closure with Prineo.

Primary Outcome Measures

Name	Time	Method
Operative Time to Closure of Final Skin Layer	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

Name	Time	Method
Score on Patient Observer Scar Assessment Scale (POSAS)	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States