NCT00547638

Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure

Multicenter, Prospective, Randomized Controlled Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Closure of Simple, Thoroughly Cleansed, Trauma-induced Wounds in the Emergency Department

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The objective of this study is to demonstrate whether the incidence of wound closure for DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.

Detailed description

According to the literature, cyanoacrylate adhesives (topical skin adhesive) have performed as intended and have not produced results that would bring into question the safety or effectiveness of cyanoacrylate adhesive for closure of surgical incisions and traumatic wounds in humans. As such, this is a multicenter, prospective, randomized controlled study for the purpose of comparing two forms of topical skin adhesives, DERMABOND PROTAPE \& DERMABOND HVD for closure of wounds in the Emergency Department. Patients presenting in the Emergency Department with traumatic wounds meeting the acceptance criteria will have their wounds closed with DERMABOND PROTAPE or DERMABOND HVD, and will be monitored and evaluated at 14 \& 30 days.

Conditions

• Lacerations

Interventions

Type	Name	Description
DEVICE	cyanoacrylate with pressure sensitive mesh	Topical Skin Adhesive
DEVICE	cyanoacrylate	Topical Skin Adhesive

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-10-22
• Last updated: 2013-08-06
• Results posted: 2013-08-06

Locations

9 sites across 1 country: United States