Use of Prineo in Breast Reduction Surgery

Efficiency of Surgical Incision Closure Clinical Trial

— Prineo  

Official title:

Use of Prineo™ for Wound Closure in Breast Reduction Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996917
• Other study ID #: AAAM2053
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Efficiency of Surgical Incision Closure
• Post-operative Scar
• Surgical Wound

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Ethicon, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. — View Citation

Dunst KM, Auboeck J, Zahel B, Raffier B, Huemer GM. Extensive allergic reaction to a new wound closure device (Prineo). Allergy. 2010 Jun 1;65(6):798-9. doi: 10.1111/j.1398-9995.2009.02243.x. Epub 2009 Nov 11. — View Citation

van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Score on the Vancouver Scar Scale (VSS)	A blinded plastic surgeon will evaluate objective scar quality using the Vancouver Scar Scale (VSS). Range of scores is from 0-13 with a higher score indicative of a worse scar.	Up to 1 year
Primary	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	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