N/A N=21 Randomized Double-blind Treatment

Use of Prineo in Breast Reduction Surgery

Efficiency of Surgical Incision Closure · Post-operative Scar

Bottom Line

View on ClinicalTrials.gov: NCT01996917 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Operative Time to Closure of Final Skin Layer — 58.38; 444.76 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Prineo (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Columbia University
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Operative Time to Closure of Final Skin Layer	58.38; 444.76	—
SECONDARY Score on Patient Observer Scar Assessment Scale (POSAS)	30.5; 32; 25; 25.5	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01996917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.