CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Prineodevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01996917
NCT01996917N/ACompleted

Use of Prineo™ for Wound Closure in Breast Reduction Surgery

Columbia University·interventional·Posted Nov 27, 2013·Updated May 7, 2019

In Brief

A clinical study evaluating Prineo for Efficiency of Surgical Incision Closure and Post-operative Scar. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsEthicon, Inc.

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 27, 2013
Enrollment StartAug 1, 2014
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.6 years ago

Interventions

Prineodevice

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.