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

Macromastia Clinical Trial

Official title: 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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macromastia

• NCT number: NCT00558246
• Study type: Interventional
• Source: Ethicon, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: August 2007
• Completion date: October 2009