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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ethicon, Inc.
- Enrollment
- 216
- Locations
- 18
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- Cosmesis(30 days (±5 days))