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

Phase 2

Completed

Interventions: Device: cyanoacrylate with pressure sensitive mesh
Device: cyanoacrylate

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Dermabond Protape	cyanoacrylate with pressure sensitive mesh	DERMABOND PROTAPE (Prineo) Topical Skin Adhesive
Dermabond HVD	cyanoacrylate	DERMABOND HVD Topical Skin Adhesive

Primary Outcome Measures

Name	Time	Method
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.	14 days (±2 days)	Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.

Secondary Outcome Measures

Name	Time	Method
Cosmesis	30 days (±5 days)	The evaluation of healing and cosmetic outcome post-treatment using the modified Hollander Cosmesis Scale (mHCS). The proportion of patients with a zero (0) score will be compared between the test and control arms.

Locations (9): NextCare Institute For Clinical Research
🇺🇸
Phoenix, Arizona, United States
Tulane Universtiy Hospital & Clinic
🇺🇸
New Orleans, Louisiana, United States
Orlando Regional Healthcare System
🇺🇸
Orlando, Florida, United States
Wake Forest University Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Investigators Research Group, LLC
🇺🇸
Indianapolis, Indiana, United States
Stony Brook University HSC
🇺🇸
Stony Brook, New York, United States
Duke University Health System
🇺🇸
Durham, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Drexel University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States