Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
Completed · Not applicable
Conditions studied: Traumatic Lacerations or Surgical Incisions
In brief
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™.
Key facts
- Study ID
- NCT01716013
- Run by
- OptMed, Inc.
- People needed
- 162
- Starts
- 2012-09-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2017-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
- Has a wound requiring surgical repair, where the use of a tissue adhesive is appropriate
- Is in good general health
- 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
You may not qualify if…
- Significant or multiple traumas
- Known peripheral vascular disease
- Known diabetes mellitus type 1 or type 2
- Known blood clotting disorder
- Patient or family history of keloid formation or hypertrophy
- Known HIV seropositivity or is immunocompromised
- Been treated with an investigational drug or medical device in the past 30 days
- A hypersensitivity or contraindication to any of the components of BondEase™
- Known pre-operative systemic or local infection
- Any other diseases or conditions which might interfere with the wound healing process
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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