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

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

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™.

Study Overview

• Status: Completed
• Conditions: Traumatic Lacerations or Surgical Incisions
• Intervention / Treatment: Device: BondEase; Procedure: CWCD

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • DC Cosmetics
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • New York, New York, United States, 10075
      • Sadick Research Group
  • North Carolina
    • Wake Forest, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BondEase; Topical Skin Adhesive	Device: BondEase; topical skin adhesive
ACTIVE_COMPARATOR: CWCD; Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips	Procedure: CWCD; traditional closure methods of sutures, staples or adhesive strips

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
100% Wound Apposition at 10 Days	Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days
≥ 50% Wound Apposition at 10 Days	Incidence of wounds ≥50% apposed (10 ± 3 days)	10 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Dehiscence Requiring Treatment	Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up	28 Days and 90 days

Collaborators and Investigators

• Sponsor: OptMed, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: October 21, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (ESTIMATE): October 29, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 9, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound; Lacerations
• Other Study ID Numbers: PD-100-002