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.

Study Overview

• Status: Completed
• Conditions: Lacerations
• Intervention / Treatment: Device: cyanoacrylate with pressure sensitive mesh; Device: cyanoacrylate

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
• Enrollment (Actual): 216
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • NextCare Institute For Clinical Research
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Regional Healthcare System
  • Indiana
    • Indianapolis, Indiana, United States, 46268
      • Investigators Research Group, Llc
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Universtiy Hospital & Clinic
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University HSC
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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%.	14 days (±2 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmesis	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.	30 days (±5 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and 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.	Through Day 30
The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature 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.	At Day 14 and Day 30
Incidence of Skin Blistering at 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.	Day 14
Incidence of Any Other Anticipated or Unanticipated Adverse Events	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.	Day 30

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Study Director: Helen Colquhoun, MD, Pleiad Devices

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: October 17, 2007
• First Submitted That Met QC Criteria: October 19, 2007
• First Posted (Estimate): October 22, 2007

Study Record Updates

• Last Update Posted (Estimate): August 6, 2013
• Last Update Submitted That Met QC Criteria: August 2, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: laceration/wound closure; topical skin adhesive
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: 07CS005; IDE Number:G060268 (Other Identifier: FDA)