Traumatic Lacerations or Surgical IncisionsNCT01716013
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
A study testing BondEase and CWCD in people with Traumatic Lacerations or Surgical Incisions, run by OptMed, Inc. at 6 sites in United States.
Trial 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™. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Lacerations or Surgical Incisions
- What is being tested?
- BondEase and CWCD
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Albany Medical Center
Albany, New York, 12208
DC Cosmetics
Chevy Chase, Maryland, 20815
Northwestern University
Chicago, Illinois, 60611
Sadick Research Group
New York, New York, 10075
Orlando Regional Medical Center
Orlando, Florida, 32806
Wake Forest Baptist Health
Wake Forest, North Carolina, 27157
About this study
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
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™.
Read the 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.
- Being tested
- BondEase, CWCD
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BondEaseDevice
topical skin adhesive
CWCDProcedure or surgery
traditional closure methods of sutures, staples or adhesive strips
| Study group | Role | What they receive |
|---|---|---|
| BondEase | Experimental | Topical Skin Adhesive Receives: Device: BondEase |
| CWCD | Active comparator | Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips Receives: Procedure: CWCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
100% Wound Apposition at 10 Days
Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.
Measured: 10 days
Secondary outcomes (2)
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.
Measured: 28 days
≥ 50% Wound Apposition at 10 Days
Incidence of wounds ≥50% apposed (10 ± 3 days)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Lacerations or Surgical IncisionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- OptMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716013
- Sponsor's protocol ID
- PD-100-002
- Status last verified
- Nov 2016
- First submitted
- 21 Oct 2012
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01716013
- Acronym / sponsor ID
- PD-100-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- OptMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Posted 18 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BondEase | Experimental | Device: BondEaseTopical Skin Adhesive |
| CWCD | Active comparator | Procedure: CWCDConventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BondEasetopical skin adhesive | Device | BondEase |
| CWCDtraditional closure methods of sutures, staples or adhesive strips | Procedure or surgery | CWCD |
Primary outcome
100% Wound Apposition at 10 Days
Time frame: 10 days
Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.
2 secondary outcomes
Optimal Cosmetic Outcome at 28 Days (Score of 6)
Time frame: 28 days
≥ 50% Wound Apposition at 10 Days
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BondEase and CWCD in people with Traumatic Lacerations or Surgical Incisions, run by OptMed, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100% Wound Apposition at 10 Days (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.