NCT00557947

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

Multi-centre Study to Show Equivalence of Prineo (Dermabond Protape) to Intradermal Sutures for Skin Closure of Full-thickness Surgical Incisions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Surgical Incisions

Interventions

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

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-04-01
• Completion: 2009-04-01
• 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