Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
This study has been completed.
Sponsor:
Ethicon, Inc.
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00547638
First received: October 17, 2007
Last updated: July 18, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lacerations |
Device: cyanoacrylate with pressure sensitive mesh Device: cyanoacrylate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Further study details as provided by Ethicon, Inc.:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: 30 days (±5 days) ] [ Designated as safety issue: No ]
- comparison of test and control arms regarding incidence of the following events: dehiscence, clinical infection, local acute inflammatory reactions, skin blistering and other adverse events [ Time Frame: duration of trial until resolution of AE or stable enpoint achieved ] [ Designated as safety issue: Yes ]
| Enrollment: | 216 |
| Study Start Date: | August 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
DERMABOND PROTAPE
|
Device: cyanoacrylate with pressure sensitive mesh
Topical Skin Adhesive
Other Names:
|
|
Active Comparator: II
DERMABOND HVD
|
Device: cyanoacrylate
Topical Skin Adhesive
Other Names:
|
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| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547638
Locations
| United States, Arizona | |
| NextCare Institute For Clinical Research | |
| Phoenix, Arizona, United States, 85016 | |
| United States, Florida | |
| Orlando Regional Healthcare System | |
| Orlando, Florida, United States, 32806 | |
| United States, Indiana | |
| Investigators Research Group, LLC | |
| Indianapolis, Indiana, United States, 46268 | |
| United States, Louisiana | |
| Tulane Universtiy Hospital & Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, New York | |
| Stony Brook University HSC | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Duke University Health System | |
| Durham, North Carolina, United States, 27710 | |
| Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Drexel University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102 | |
Sponsors and Collaborators
Ethicon, Inc.
Investigators
| Study Director: | Helen Colquhoun, MD | Pleiad Devices |
More Information
No publications provided
| Responsible Party: | Ethicon, Inc. |
| ClinicalTrials.gov Identifier: | NCT00547638 History of Changes |
| Other Study ID Numbers: | 07CS005, IDE Number:G060268 |
| Study First Received: | October 17, 2007 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ethicon, Inc.:
|
laceration/wound closure topical skin adhesive |
Additional relevant MeSH terms:
|
Lacerations Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013