Use of Prineo in Breast Reduction Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Efficiency of Surgical Incision Closure Post-operative Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Prineo closure

One breast will have skin closure with Prineo.

Group Type ACTIVE_COMPARATOR

Prineo

Intervention Type 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.

Standard Suture

One breast will be closed in the standard fashion with suture.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Prineo wound closure system

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No