Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions

OptMed

Status: Completed

Conditions: Traumatic Lacerations or Surgical Incisions

Treatments: Procedure: CWCD; Device: BondEase

Study type: Interventional

Funder types: Industry

Identifiers

NCT01716013

PD-100-002

Details and patient eligibility

About

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™.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

BondEase

Experimental group

Description:

Topical Skin Adhesive

Treatment:

Device: BondEase

CWCD

Active Comparator group

Description:

Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips

Treatment:

Procedure: CWCD