Use of Prineo in Breast Reduction Surgery

Study Overview
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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.

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.

Official Title
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Use of Prineo™ for Wound Closure in Breast Reduction Surgery

Conditions
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Efficiency of Surgical Incision Closure, Post-operative Scar

Intervention / Treatment
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* Device: Prineo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prineo closure<br>One breast will have skin closure with Prineo. | Device: Prineo<br>* 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.<br>* Other names: Prineo wound closure system;|
| No Intervention: Standard Suture<br>One breast will be closed in the standard fashion with suture. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time to Closure of Final Skin Layer | This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures. | During operation only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Patient Observer Scar Assessment Scale (POSAS) | 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. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound closure, prineo, scar