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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547638
Recruitment Status : Completed
First Posted : October 22, 2007
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Information provided by (Responsible Party):
Ethicon, Inc.

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.

Condition or disease Intervention/treatment Phase
Lacerations Device: cyanoacrylate with pressure sensitive mesh Device: cyanoacrylate Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dermabond Protape
DERMABOND PROTAPE (Prineo) Topical Skin Adhesive
Device: cyanoacrylate with pressure sensitive mesh
Topical Skin Adhesive
Other Names:
  • Dermabond Protape
  • Prineo

Active Comparator: Dermabond HVD
DERMABOND HVD Topical Skin Adhesive
Device: cyanoacrylate
Topical Skin Adhesive
Other Names:
  • Dermabond - HVD
  • Dermabond - Protape

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cosmesis [ Time Frame: 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.

Other Outcome Measures:
  1. The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 [ Time Frame: Through Day 30 ]
    Incidence of clinical infection (defined by observation of redness, swelling, purulent discharge, pain, increased skin temperature, fever or other systemic signs of injection) collected at the Day 14 and Day 30 visits. A formal statistical analysing using Fisher's Exact Test was performed.

  2. The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 [ Time Frame: At Day 14 and Day 30 ]
    Each parameter (edema, erythema, pain and location temperature) is measured on a 4 point scale (0, 1, 2, 3). The individual values are added to generate an overall AIRE Score. AIRE Scores were summarized as good (score=0) versus poor (score>0) by treatment group and compared for differences using the Fisher's Exact Test.

  3. Incidence of Skin Blistering at Day 14 [ Time Frame: Day 14 ]
    The incidence of skin blistering is presented as a tabulation of the presence or absence of skin blistering by treatment group. A formal statistical analysis of the incidence of blistering at Day 14 was performed using the Fisher's Exact Test.

  4. Incidence of Any Other Anticipated or Unanticipated Adverse Events [ Time Frame: Day 30 ]
    Adverse events were coded using the MedDRA dictionary. In addition severity, relationship to treatment and procedure, action taken and outcome were described. Adverse events were summarized by treatment group. No formal statistical analysis was performed on overall incidence of adverse events with the exception of clinical infection, acute inflammatory reactions and skin blistering.

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00547638

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
Drexel University Hospital
Philadelphia, Pennsylvania, United States, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Ethicon, Inc.
Study Director: Helen Colquhoun, MD Pleiad Devices

Responsible Party: Ethicon, Inc. Identifier: NCT00547638     History of Changes
Other Study ID Numbers: 07CS005
IDE Number:G060268 ( Other Identifier: FDA )
First Posted: October 22, 2007    Key Record Dates
Results First Posted: August 6, 2013
Last Update Posted: August 6, 2013
Last Verified: August 2013

Keywords provided by Ethicon, Inc.:
laceration/wound closure
topical skin adhesive

Additional relevant MeSH terms:
Wounds and Injuries