Use of Prineo in Breast Reduction Surgery

NCT01996917 | Completed Results

• 1 other identifier: AAAM2053
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Efficiency of Surgical Incision Closure; Post-operative Scar

Keywords

wound closure; prineo; scar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Score on Patient Observer Scar Assessment Scale (POSAS)

  Up to 1 year

Other Outcomes (1)

• Score on the Vancouver Scar Scale (VSS)

  Up to 1 year

Study Arms (2)

Prineo closure

ACTIVE COMPARATOR

One breast will have skin closure with Prineo.

Device: Prineo

Standard Suture

NO INTERVENTION

One breast will be closed in the standard fashion with suture.

Interventions

Prineo DEVICE

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.

Also known as: Prineo wound closure system

Prineo closure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Columbia University: lead
• Ethicon, Inc.: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10021, United States

Location

Related 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. doi: 10.1097/01.prs.0000122207.28773.56.

  PMID: 15253184 BACKGROUND

• 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. doi: 10.1097/01.prs.0000172982.43599.d6.

  PMID: 16079683 BACKGROUND

• 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. No abstract available.

  PMID: 19909297 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christine Rohde, MD
• Organization: Columbia University

chr2111@cumc.columbia.edu

212-342-3707

Study Officials

• Christine Rohde, MD,MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: August 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-04

Locations

US (1)