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

NCT ID: NCT01716013

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-02-28

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.

Conditions

Traumatic Lacerations or Surgical Incisions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BondEase

Topical Skin Adhesive

Group Type: EXPERIMENTAL

BondEase

Intervention Type: DEVICE

topical skin adhesive

CWCD

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

Group Type: ACTIVE_COMPARATOR

CWCD

Intervention Type: PROCEDURE

traditional closure methods of sutures, staples or adhesive strips

Interventions

BondEase

topical skin adhesive

Intervention Type: DEVICE

CWCD

traditional closure methods of sutures, staples or adhesive strips

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OptMed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orlando Regional Medical Center

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

DC Cosmetics

Chevy Chase, Maryland, United States

Albany Medical Center

Albany, New York, United States

Sadick Research Group

New York, New York, United States

Wake Forest Baptist Health

Wake Forest, North Carolina, United States

Countries

United States

Other Identifiers

PD-100-002

Identifier Type: -

Identifier Source: org_study_id