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

October 17, 2007
August 2, 2013
August 2007
March 2009   (final data collection date for primary outcome 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. [ 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%.
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) ]
Complete list of historical versions of study NCT00547638 on ClinicalTrials.gov Archive Site
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.
  • 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) ]
  • 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 ]
  • 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.
Not Provided
 
Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lacerations
  • Device: cyanoacrylate with pressure sensitive mesh
    Topical Skin Adhesive
    Other Names:
    • Dermabond Protape
    • Prineo
  • Device: cyanoacrylate
    Topical Skin Adhesive
    Other Names:
    • Dermabond - HVD
    • Dermabond - Protape
  • Experimental: Dermabond Protape
    DERMABOND PROTAPE (Prineo) Topical Skin Adhesive
    Intervention: Device: cyanoacrylate with pressure sensitive mesh
  • Active Comparator: Dermabond HVD
    DERMABOND HVD Topical Skin Adhesive
    Intervention: Device: cyanoacrylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
216
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547638
07CS005, IDE Number:G060268
No
Ethicon, Inc.
Ethicon, Inc.
Not Provided
Study Director: Helen Colquhoun, MD Pleiad Devices
Ethicon, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP