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

Ethicon

Status and phase

Completed

Phase 2

Conditions

Lacerations

Treatments

Device: cyanoacrylate

Device: cyanoacrylate with pressure sensitive mesh

Study type

Interventional

Funder types

Industry

Identifiers

NCT00547638

IDE Number:G060268 (Other Identifier)

07CS005

Details and patient eligibility

About

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.

Full 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.

Enrollment

216 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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