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

Primary Purpose

Lacerations

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cyanoacrylate with pressure sensitive mesh
cyanoacrylate
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lacerations focused on measuring laceration/wound closure, topical skin adhesive

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NextCare Institute For Clinical Research
  • Orlando Regional Healthcare System
  • Investigators Research Group, LLC
  • Tulane Universtiy Hospital & Clinic
  • Stony Brook University HSC
  • Duke University Health System
  • Wake Forest University Baptist Medical Center
  • Drexel University Hospital
  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dermabond Protape

Dermabond HVD

Arm Description

DERMABOND PROTAPE (Prineo) Topical Skin Adhesive

DERMABOND HVD Topical Skin Adhesive

Outcomes

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.
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
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.

Full Information

First Posted
October 17, 2007
Last Updated
August 2, 2013
Sponsor
Ethicon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00547638
Brief Title
Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacerations
Keywords
laceration/wound closure, topical skin adhesive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dermabond Protape
Arm Type
Experimental
Arm Description
DERMABOND PROTAPE (Prineo) Topical Skin Adhesive
Arm Title
Dermabond HVD
Arm Type
Active Comparator
Arm Description
DERMABOND HVD Topical Skin Adhesive
Intervention Type
Device
Intervention Name(s)
cyanoacrylate with pressure sensitive mesh
Other Intervention Name(s)
Dermabond Protape, Prineo
Intervention Description
Topical Skin Adhesive
Intervention Type
Device
Intervention Name(s)
cyanoacrylate
Other Intervention Name(s)
Dermabond - HVD, Dermabond - Protape
Intervention Description
Topical Skin Adhesive
Primary Outcome Measure Information:
Title
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.
Description
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%.
Time Frame
14 days (±2 days)
Secondary Outcome Measure Information:
Title
Cosmesis
Description
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)
Other Pre-specified Outcome Measures:
Title
The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30
Description
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.
Time Frame
Through Day 30
Title
The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30
Description
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.
Time Frame
At Day 14 and Day 30
Title
Incidence of Skin Blistering at Day 14
Description
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.
Time Frame
Day 14
Title
Incidence of Any Other Anticipated or Unanticipated Adverse Events
Description
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.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Colquhoun, MD
Organizational Affiliation
Pleiad Devices
Official's Role
Study Director
Facility Information:
Facility Name
NextCare Institute For Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Orlando Regional Healthcare System
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigators Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46268
Country
United States
Facility Name
Tulane Universtiy Hospital & Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Stony Brook University HSC
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Drexel University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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