Traumatic Lacerations or Surgical Incisions
Conditions
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.
Interventions
DEVICEBondEase
topical skin adhesive
PROCEDURECWCD
traditional closure methods of sutures, staples or adhesive strips
Sponsors
OptMed, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 100% Wound Apposition at 10 Days | 10 days | Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ≥ 50% Wound Apposition at 10 Days | 10 days | Incidence of wounds ≥50% apposed (10 ± 3 days) |
| Optimal Cosmetic Outcome at 28 Days (Score of 6) | 28 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wound Dehiscence Requiring Treatment | 28 Days and 90 days | Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BondEase Topical Skin Adhesive
BondEase: topical skin adhesive | 105 |
| CWCD Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips | 54 |
| Total | 159 |
Baseline characteristics
| Characteristic | CWCD | BondEase | Total |
|---|---|---|---|
| Age, Continuous | 47.7 years STANDARD_DEVIATION 22.3 | 44.4 years STANDARD_DEVIATION 23.1 | 45.5 years STANDARD_DEVIATION 22.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 21 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 84 Participants | 133 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 24 Participants | 49 Participants | 73 Participants |
| Gender Male | 30 Participants | 56 Participants | 86 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 16 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 46 Participants | 83 Participants | 129 Participants |
| Wound type Injury (Laceration) | 13 participants | 27 participants | 40 participants |
| Wound type Surgical incision | 41 participants | 78 participants | 119 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 105 | 6 / 54 |
| serious Total, serious adverse events | 0 / 105 | 0 / 54 |
Outcome results
Primary
100% Wound Apposition at 10 Days
Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.
Time frame: 10 days
Population: Per protocol population (primary analysis dataset)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BondEase | 100% Wound Apposition at 10 Days | 77.1 percentage of participants |
| CWCD | 100% Wound Apposition at 10 Days | 80.4 percentage of participants |
Secondary
≥ 50% Wound Apposition at 10 Days
Incidence of wounds ≥50% apposed (10 ± 3 days)
Time frame: 10 days
Population: Intent-to-treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BondEase | ≥ 50% Wound Apposition at 10 Days | 93.3 percentage of participants |
| CWCD | ≥ 50% Wound Apposition at 10 Days | 96.3 percentage of participants |
Secondary
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.
Time frame: 28 days
Population: Intent-to-treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BondEase | Optimal Cosmetic Outcome at 28 Days (Score of 6) | 70.5 percentage of participants |
| CWCD | Optimal Cosmetic Outcome at 28 Days (Score of 6) | 64.8 percentage of participants |
Other Pre-specified
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
Time frame: 28 Days and 90 days
Population: Intent-to-Treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BondEase | Wound Dehiscence Requiring Treatment | 0 percentage of participants |
| CWCD | Wound Dehiscence Requiring Treatment | 0 percentage of participants |