NCT00558246

Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures

Multi-centre Study to Show Equivalence of Prineo (DERMABOND PROTAPE) to Intradermal Sutures for Skin Closure of Full-thickness Surgical Incisions Associated With Breast Procedures

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures. Breast procedures where symmetrical incisions of at least 15cm in length are planned for both breast (bilateral procedure) will be randomised to receive final skin closure of one breast with Prineo (DERMABOND PROTAPE) and the other with intradermal sutures (control). Patients will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).

Conditions

• Macromastia

Interventions

Type	Name	Description
DEVICE	Dermabond Protape (Prineo)	cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
DEVICE	Suture	Topical Suturing

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-09-01
• Completion: 2009-10-01
• First posted: 2007-11-14
• Last updated: 2012-07-19
• Results posted: 2012-07-19

Locations

5 sites across 4 countries: Belgium, Germany, Sweden, United Kingdom