MedTrace Logo

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

NCT00558246 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2012-07-19

Study results available
· View outcomes & findings →

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

DEVICE

Dermabond Protape (Prineo)

cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive

DEVICE

Suture

Topical Suturing

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Helen Colquhoun, MD · Pleiad Devices

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-09-30
Completion
2009-10-31

Countries

  • Belgium
  • Germany
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00558246 on ClinicalTrials.gov