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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00547638
First received: October 17, 2007
Last updated: August 2, 2013
Last verified: August 2013
  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 ]
    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:
  • Cosmesis [ Time Frame: 30 days (±5 days) ] [ Designated as safety issue: No ]
    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:
  • The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 [ Time Frame: Through Day 30 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Incidence of Skin Blistering at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
    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.

  • Incidence of Any Other Anticipated or Unanticipated Adverse Events [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
    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.


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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: March 1, 2013
Last Updated: August 2, 2013
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 July 20, 2014