Clinical trial NCT01716013: 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
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Lacerations or Surgical Incisions
Lead sponsor: OptMed, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Has a wound requiring surgical repair, where the use of a tissue adhesive is appropriate
3. Is in good general health
4. 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:

1. Significant or multiple traumas
2. Known peripheral vascular disease
3. Known diabetes mellitus type 1 or type 2
4. Known blood clotting disorder
5. Patient or family history of keloid formation or hypertrophy
6. Known HIV seropositivity or is immunocompromised
7. Been treated with an investigational drug or medical device in the past 30 days
8. A hypersensitivity or contraindication to any of the components of BondEase™
9. Known pre-operative systemic or local infection
10. Any other diseases or conditions which might interfere with the wound healing process
11. 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

Primary outcomes:
measure: 100% Wound Apposition at 10 Days
timeFrame: 10 days
Secondary outcomes:
measure: Optimal Cosmetic Outcome at 28 Days (Score of 6)
timeFrame: 28 days
measure: ≥ 50% Wound Apposition at 10 Days
timeFrame: 10 days
Other outcomes:
measure: Wound Dehiscence Requiring Treatment
timeFrame: 28 Days and 90 days
Locations:
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chevy Chase
country: United States
facility: DC Cosmetics
state: Maryland
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Wake Forest
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
References: