Back to resultsSafety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
Primary Purpose
Traumatic Lacerations or Surgical Incisions
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BondEase
CWCD
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Lacerations or Surgical Incisions
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects at least 1 year of age (for Part 2 only) or at least 18 years of age (for both Part 1 and Part 2).
- Has a wound requiring surgical repair, where the use of a tissue adhesive is appropriate
- Is in good general health
- Subject or the guardian understands and is willing to sign informed consent prior to study entry and agrees to be available for the Day 10, Day 28, and Day 90 (Part 1/pilot phase only) follow-up visits
Exclusion Criteria:
- Significant or multiple traumas
- Known peripheral vascular disease
- Known diabetes mellitus type 1 or type 2
- Known blood clotting disorder
- Patient or family history of keloid formation or hypertrophy
- Known HIV seropositivity or is immunocompromised
- Been treated with an investigational drug or medical device in the past 30 days
- A hypersensitivity or contraindication to any of the components of BondEase™
- Known pre-operative systemic or local infection
- Any other diseases or conditions which might interfere with the wound healing process
The wound to be treated with the test device may not have any of the following characteristics:
- A "burst" or stellate laceration
- Heavily contaminated (Contaminated Wound: wounds that are grossly contaminated with foreign material requiring extensive cleansing.
- Human or animal bite
- Decubitus etiology
- Evidence of active infection or gangrene
- On mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips)
- On an area which may be regularly exposed to body fluids or with dense natural hair, (e.g., scalp)
- Under tension or over a joint
Sites / Locations
- Orlando Regional Medical Center
- Northwestern University
- DC Cosmetics
- Albany Medical Center
- Sadick Research Group
- Wake Forest Baptist Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BondEase
CWCD
Arm Description
Topical Skin Adhesive
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
Outcomes
Primary Outcome Measures
100% Wound Apposition at 10 Days
Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.
Secondary Outcome Measures
Optimal Cosmetic Outcome at 28 Days (Score of 6)
Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.
One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:
Stepoff of borders (edges not on the same plane)
Contour irregularities (wrinkled skin near wound)
Margin separation (gap between sides)
Edge inversion (wound not properly everted)
Excessive distortion (swelling or edema or infection)
Poor overall appearance.
The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal.
≥ 50% Wound Apposition at 10 Days
Incidence of wounds ≥50% apposed (10 ± 3 days)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01716013
Brief Title
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
Official Title
A Multi-Center, Prospective, Open-label, Randomized Study of the Safety and Efficacy of BondEase™ Topical Skin Adhesive for the Closure of Traumatic Lacerations and Surgical Incisions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OptMed, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in terms of cosmesis (appearance) of the repaired wound when these devices are used for closure of surgical and traumatic wounds .
To demonstrate safety of BondEase™.
Detailed Description
This is a two-phase, multi-center, prospective, randomized, parallel-group study, in which a total of 153 subjects (102 in the BondEase™ group and 51 in the CWCD group) with traumatic lacerations and incisions will be enrolled. Overall, eligible subjects will be randomized in a pre-defined 2:1 ratio to BondEase™ skin adhesive or CWCD.
In Part 1 of the study 30 subjects will be randomized in a 2:1 ratio (BondEase™ : CWCD). This part of the study is designed to assess the feasibility and validate use of the device. Pediatric subjects younger than age 18 will not be included in this part of the trial. The results from these 30 subjects will be compiled and submitted to FDA for review and approval prior to proceeding with Part 2. Part 2 of the study will only be initiated after FDA indicates it is acceptable to begin. In Part 2 of the study a total of 123 subjects will be randomized, of which 82 subjects will be randomized to the BondEase™ group and 41 subjects to the CWCD group. This will result in 102 subjects in the BondEase™ group and 51 subjects in the CWCD group across the both parts of the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Lacerations or Surgical Incisions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BondEase
Arm Type
Experimental
Arm Description
Topical Skin Adhesive
Arm Title
CWCD
Arm Type
Active Comparator
Arm Description
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
Intervention Type
Device
Intervention Name(s)
BondEase
Intervention Description
topical skin adhesive
Intervention Type
Procedure
Intervention Name(s)
CWCD
Intervention Description
traditional closure methods of sutures, staples or adhesive strips
Primary Outcome Measure Information:
Title
100% Wound Apposition at 10 Days
Description
Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Optimal Cosmetic Outcome at 28 Days (Score of 6)
Description
Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.
One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:
Stepoff of borders (edges not on the same plane)
Contour irregularities (wrinkled skin near wound)
Margin separation (gap between sides)
Edge inversion (wound not properly everted)
Excessive distortion (swelling or edema or infection)
Poor overall appearance.
The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal.
Time Frame
28 days
Title
≥ 50% Wound Apposition at 10 Days
Description
Incidence of wounds ≥50% apposed (10 ± 3 days)
Time Frame
10 days
Other Pre-specified Outcome Measures:
Title
Wound Dehiscence Requiring Treatment
Description
Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up
Time Frame
28 Days and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects at least 1 year of age (for Part 2 only) or at least 18 years of age (for both Part 1 and Part 2).
Has a wound requiring surgical repair, where the use of a tissue adhesive is appropriate
Is in good general health
Subject or the guardian understands and is willing to sign informed consent prior to study entry and agrees to be available for the Day 10, Day 28, and Day 90 (Part 1/pilot phase only) follow-up visits
Exclusion Criteria:
Significant or multiple traumas
Known peripheral vascular disease
Known diabetes mellitus type 1 or type 2
Known blood clotting disorder
Patient or family history of keloid formation or hypertrophy
Known HIV seropositivity or is immunocompromised
Been treated with an investigational drug or medical device in the past 30 days
A hypersensitivity or contraindication to any of the components of BondEase™
Known pre-operative systemic or local infection
Any other diseases or conditions which might interfere with the wound healing process
The wound to be treated with the test device may not have any of the following characteristics:
A "burst" or stellate laceration
Heavily contaminated (Contaminated Wound: wounds that are grossly contaminated with foreign material requiring extensive cleansing.
Human or animal bite
Decubitus etiology
Evidence of active infection or gangrene
On mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips)
On an area which may be regularly exposed to body fluids or with dense natural hair, (e.g., scalp)
Under tension or over a joint
Facility Information:
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
DC Cosmetics
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Wake Forest Baptist Health
City
Wake Forest
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
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