Clinical trial NCT00547638: Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lacerations
Keywords: laceration/wound closure
topical skin adhesive
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-22
Enrollment: 216
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 14 days (±2 days)
Secondary outcomes:
measure: Cosmesis
timeFrame: 30 days (±5 days)
Other outcomes:
measure: The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30
timeFrame: Through Day 30
measure: The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30
timeFrame: At Day 14 and Day 30
measure: Incidence of Skin Blistering at Day 14
timeFrame: Day 14
measure: Incidence of Any Other Anticipated or Unanticipated Adverse Events
timeFrame: Day 30
Locations:
city: Phoenix
country: United States
facility: NextCare Institute For Clinical Research
state: Arizona
city: Orlando
country: United States
facility: Orlando Regional Healthcare System
state: Florida
city: Indianapolis
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: New Orleans
country: United States
facility: Tulane Universtiy Hospital & Clinic
state: Louisiana
city: Stony Brook
country: United States
facility: Stony Brook University HSC
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Drexel University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Pleiad Devices
name: Helen Colquhoun, MD
role: STUDY_DIRECTOR
References: