Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions

Surgical Incisions 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

Status Completed

Clinical Trial Summary

This is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions. Each incision included in the study will be segmented into two halves; each half will be randomized to receive final skin closure with either Prineo (DERMABOND PROTAPE) or intradermal sutures. Subjects 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

• Surgical Incisions

• NCT number: NCT00557947
• Study type: Interventional
• Source: Ethicon, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: August 2007
• Completion date: April 2009