Phase 2 N=216 Randomized Treatment

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

Lacerations

Bottom Line

View on ClinicalTrials.gov: NCT00547638 ↗

Enrolled (actual)

216

Serious AEs

0.0%

Results posted

Aug 2013

Primary outcome: Primary: The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure. — 123; 57 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cyanoacrylate with pressure sensitive mesh (Device); cyanoacrylate (Device)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Ethicon, Inc.
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure.	123; 57	—
SECONDARY Cosmesis	93; 43	0.457

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00547638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.