Use of Prineo in Breast Reduction Surgery
Completed · Not applicable
Conditions studied: Efficiency of Surgical Incision Closure, Post-operative Scar
In brief
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.
Key facts
- Study ID
- NCT01996917
- Run by
- Columbia University
- People needed
- 21
- Starts
- 2014-08-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2019-05-07
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women undergoing Wise pattern breast reductions for symptomatic macromastia.
You may not qualify if…
- 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.
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.