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

Completed · Phase 2

Conditions studied: Lacerations

In brief

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.

Key facts

Study ID

NCT00547638

Run by

Ethicon, Inc.

People needed

216

Starts

2007-08-01

Expected to finish

2009-03-01

Last updated by the study team

2013-08-06

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• at least 1 year of age
• in good general health in the opinion of the Investigator.
• have at least one traumatic wound meeting the criteria for closure as defined in current Dermabond product labeling.
• patient must be willing to follow instructions for wound care listed in device labeling and refrain from picking at the device, applying topical medications to the wound, and swimming or soaking in a tub until the sutures are removed.
• patient agrees to return for follow-up evaluation
• patient (or guardian) signs the informed consent
• patient is reasonably expected to survive the study

You may not qualify if…

• significant multiple trauma (merely multiple wounds are allowed)
• peripheral vascular disease
• insulin dependent diabetes mellitus
• known to have a blood clotting disorder
• receiving antibiotic therapy for preexisting condition or infection
• known to be HIV-positive or otherwise immunocompromised
• known personal or family history of keloid formation or hypertrophy
• currently taking systemic steroids
• known allergy to cyanoacrylate, formaldehyde, tapes or adhesives
• participating in another current clinical study
• history of abnormal wound healing
• burst stellate lacerations due to a crush or hard blow
• animal or human bite or scratch
• decubitus ulcer
• puncture wound
• wound at mucocutaneous junction or in mucosal (but not excluding the vermillion border of the lip)
• wound on scalp covered by natural hair
• wound has visual evidence of active infection
• gangrenous wound
• wound requiring debridement of devitalized or contaminated tissue
• wound at site of active rash/skin lesion making evaluation difficult
• previously treated wound or has failed to heal
• wound in high skin tension area or across an area of increased skin tension, such as knuckles, elbows, or knees, unless the joint will be immobilized during the skin healing period or unless skin tension has been removed by application

Where it is running

• NextCare Institute For Clinical Research — Phoenix, Arizona, United States
• Orlando Regional Healthcare System — Orlando, Florida, United States
• Investigators Research Group, LLC — Indianapolis, Indiana, United States
• Tulane Universtiy Hospital & Clinic — New Orleans, Louisiana, United States
• Stony Brook University HSC — Stony Brook, New York, United States
• Duke University Health System — Durham, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Drexel University Hospital — Philadelphia, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.