N/A
N=162
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
Traumatic Lacerations or Surgical Incisions
Bottom Line
View on ClinicalTrials.gov: NCT01716013 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: 100% Wound Apposition at 10 Days — 77.1; 80.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BondEase (Device); CWCD (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OptMed, Inc.
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 100% Wound Apposition at 10 Days |
77.1; 80.4 | — |
| SECONDARY Optimal Cosmetic Outcome at 28 Days (Score of 6) |
70.5; 64.8 | — |
| SECONDARY ≥ 50% Wound Apposition at 10 Days |
93.3; 96.3 | — |
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™.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01716013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.