LacerationsPhase 2NCT00547638
Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
A Phase 2 study testing cyanoacrylate with pressure sensitive mesh and cyanoacrylate in people with Lacerations, run by Ethicon, Inc. at 9 sites in United States.
Trial summary
This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Lacerations
- What is being tested?
- cyanoacrylate with pressure sensitive mesh and cyanoacrylate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2007to Mar 2009
- Phase
- Phase 2
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- at least 1 year of age
- in good general health in the opinion of the Investigator.
- have at least one traumatic wound meeting the criteria for closure as defined in current Dermabond product labeling.
- patient must be willing to follow instructions for wound care listed in device labeling and refrain from picking at the device, applying topical medications to the wound, and swimming or soaking in a tub until the sutures are removed.
- patient agrees to return for follow-up evaluation
- patient (or guardian) signs the informed consent
- patient is reasonably expected to survive the study
Who cannot join
- significant multiple trauma (merely multiple wounds are allowed)
- peripheral vascular disease
- insulin dependent diabetes mellitus
- known to have a blood clotting disorder
- receiving antibiotic therapy for preexisting condition or infection
- known to be HIV-positive or otherwise immunocompromised
Show all 23Show fewer
- known personal or family history of keloid formation or hypertrophy
- currently taking systemic steroids
- known allergy to cyanoacrylate, formaldehyde, tapes or adhesives
- participating in another current clinical study
- history of abnormal wound healing
- burst stellate lacerations due to a crush or hard blow
- animal or human bite or scratch
- decubitus ulcer
- puncture wound
- wound at mucocutaneous junction or in mucosal (but not excluding the vermillion border of the lip)
- wound on scalp covered by natural hair
- wound has visual evidence of active infection
- gangrenous wound
- wound requiring debridement of devitalized or contaminated tissue
- wound at site of active rash/skin lesion making evaluation difficult
- previously treated wound or has failed to heal
- wound in high skin tension area or across an area of increased skin tension, such as knuckles, elbows, or knees, unless the joint will be immobilized during the skin healing period or unless skin tension has been removed by application
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Duke University Health System
Durham, North Carolina, 27710
Investigators Research Group, LLC
Indianapolis, Indiana, 46268
Tulane Universtiy Hospital & Clinic
New Orleans, Louisiana, 70112
Orlando Regional Healthcare System
Orlando, Florida, 32806
Drexel University Hospital
Philadelphia, Pennsylvania, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
NextCare Institute For Clinical Research
Phoenix, Arizona, 85016
Stony Brook University HSC
Stony Brook, New York, 11794
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Multicenter, Prospective, Randomized Controlled Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Closure of Simple, Thoroughly Cleansed, Trauma-induced Wounds in the Emergency Department
This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The objective of this study is to demonstrate whether the incidence of wound closure for DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.
Read the detailed description
According to the literature, cyanoacrylate adhesives (topical skin adhesive) have performed as intended and have not produced results that would bring into question the safety or effectiveness of cyanoacrylate adhesive for closure of surgical incisions and traumatic wounds in humans.
As such, this is a multicenter, prospective, randomized controlled study for the purpose of comparing two forms of topical skin adhesives, DERMABOND PROTAPE \& DERMABOND HVD for closure of wounds in the Emergency Department.
Patients presenting in the Emergency Department with traumatic wounds meeting the acceptance criteria will have their wounds closed with DERMABOND PROTAPE or DERMABOND HVD, and will be monitored and evaluated at 14 \& 30 days.
- Conditions
- Lacerations
- Being tested
- cyanoacrylate with pressure sensitive mesh, cyanoacrylate
- Keywords
- laceration/wound closure, topical skin adhesive
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyanoacrylate with pressure sensitive meshDevice
Also called Dermabond Protape, Prineo
Topical Skin Adhesive
cyanoacrylateDevice
Also called Dermabond - HVD, Dermabond - Protape
Topical Skin Adhesive
| Study group | Role | What they receive |
|---|---|---|
| Dermabond Protape | Experimental | DERMABOND PROTAPE (Prineo) Topical Skin Adhesive Receives: Device: cyanoacrylate with pressure sensitive mesh |
| Dermabond HVD | Active comparator | DERMABOND HVD Topical Skin Adhesive Receives: Device: cyanoacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure.
Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.
Measured: 14 days (±2 days)
Secondary outcomes (1)
Cosmesis
The evaluation of healing and cosmetic outcome post-treatment using the modified Hollander Cosmesis Scale (mHCS). The proportion of patients with a zero (0) score will be compared between the test and control arms.
Measured: 30 days (±5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2009
- Study completionMar 2009
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 LacerationsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Colquhoun, MD, Study director, Pleiad Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547638
- Sponsor's protocol ID
- 07CS005
- Other IDs
- IDE Number:G060268
- Status last verified
- Aug 2013
- First submitted
- 17 Oct 2007
- Last updated
- 6 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized Controlled Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Closure of Simple, Thoroughly Cleansed, Trauma-induced Wounds in the Emergency Department
- ClinicalTrials.gov ID
- NCT00547638
- Acronym / sponsor ID
- 07CS005
- Conditions
- Lacerations
- Keywords
- laceration/wound closure, topical skin adhesive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Oct 2007 (estimated)
- Results
- Posted 6 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The objective of this study is to demonstrate whether the incidence of wound closure for DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.
Detailed description
According to the literature, cyanoacrylate adhesives (topical skin adhesive) have performed as intended and have not produced results that would bring into question the safety or effectiveness of cyanoacrylate adhesive for closure of surgical incisions and traumatic wounds in humans.
As such, this is a multicenter, prospective, randomized controlled study for the purpose of comparing two forms of topical skin adhesives, DERMABOND PROTAPE \& DERMABOND HVD for closure of wounds in the Emergency Department.
Patients presenting in the Emergency Department with traumatic wounds meeting the acceptance criteria will have their wounds closed with DERMABOND PROTAPE or DERMABOND HVD, and will be monitored and evaluated at 14 \& 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermabond Protape | Experimental | Device: cyanoacrylate with pressure sensitive meshDERMABOND PROTAPE (Prineo) Topical Skin Adhesive |
| Dermabond HVD | Active comparator | Device: cyanoacrylateDERMABOND HVD Topical Skin Adhesive |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- at least 1 year of age
- in good general health in the opinion of the Investigator.
- have at least one traumatic wound meeting the criteria for closure as defined in current Dermabond product labeling.
- patient must be willing to follow instructions for wound care listed in device labeling and refrain from picking at the device, applying topical medications to the wound, and swimming or soaking in a tub until the sutures are removed.
- patient agrees to return for follow-up evaluation
Key exclusion criteria (23 listed)
- significant multiple trauma (merely multiple wounds are allowed)
- peripheral vascular disease
- insulin dependent diabetes mellitus
- known to have a blood clotting disorder
- receiving antibiotic therapy for preexisting condition or infection
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 |
|---|---|---|
| cyanoacrylate with pressure sensitive meshAlso: Dermabond Protape, PrineoTopical Skin Adhesive | Device | Dermabond Protape |
| cyanoacrylateAlso: Dermabond - HVD, Dermabond - ProtapeTopical Skin Adhesive | Device | Dermabond HVD |
Primary outcome
The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure.
Time frame: 14 days (±2 days)
Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.
1 secondary outcome
Cosmesis
Time frame: 30 days (±5 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Helen Colquhoun, MD study director
Pleiad Devices
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyanoacrylate with pressure sensitive mesh and cyanoacrylate in people with Lacerations, run by Ethicon, Inc. at 9 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 7 inclusion and 23 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 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2013). 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?
The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure. (time frame: 14 days (±2 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 6 Aug 2013.