Traumatic Lacerations or Surgical Incisions Clinical Trial
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
| Verified date | May 2015 |
| Source | OptMed, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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™.
| Status | Completed |
| Enrollment | 162 |
| Est. completion date | February 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany Medical Center | Albany | New York |
| United States | DC Cosmetics | Chevy Chase | Maryland |
| United States | Northwestern University | Chicago | Illinois |
| United States | Sadick Research Group | New York | New York |
| United States | Orlando Regional Medical Center | Orlando | Florida |
| United States | Wake Forest Baptist Health | Wake Forest | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| OptMed, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | • 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 | Yes | |
| Primary | • Proportion of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure. | 10 days | No | |
| Secondary | • Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days (and 90 days Part 1 only) | 28 Days and 90 days | No | |
| Secondary | Incidence of wounds =50% apposed (10±3 days) | 10 days | No |