Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
NCT ID: NCT00547638
Last Updated: 2013-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
216 participants
INTERVENTIONAL
2007-08-31
2009-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dermabond Protape
DERMABOND PROTAPE (Prineo) Topical Skin Adhesive
cyanoacrylate with pressure sensitive mesh
Topical Skin Adhesive
Dermabond HVD
DERMABOND HVD Topical Skin Adhesive
cyanoacrylate
Topical Skin Adhesive
Interventions
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cyanoacrylate with pressure sensitive mesh
Topical Skin Adhesive
cyanoacrylate
Topical Skin Adhesive
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
ALL
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Helen Colquhoun, MD
Role: STUDY_DIRECTOR
Pleiad Devices
Locations
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NextCare Institute For Clinical Research
Phoenix, Arizona, United States
Orlando Regional Healthcare System
Orlando, Florida, United States
Investigators Research Group, LLC
Indianapolis, Indiana, United States
Tulane Universtiy Hospital & Clinic
New Orleans, Louisiana, United States
Stony Brook University HSC
Stony Brook, New York, United States
Duke University Health System
Durham, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Drexel University Hospital
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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IDE Number:G060268
Identifier Type: OTHER
Identifier Source: secondary_id
07CS005
Identifier Type: -
Identifier Source: org_study_id