Laceration of SkinNCT03628690
A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
A study testing BandGrip and Suture in people with Laceration of Skin, run by BandGrip at 1 site in United States.
Trial summary
an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laceration of Skin
- What is being tested?
- BandGrip and Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Female age 18-65.
- Subject presents to emergency room with at least one skin laceration that is assessed as requiring a suture closure on the trunk or extremities (excluding hands and feet).
- The length of the laceration is less than or equal to 1.5 inches.
- Subject is otherwise in good general health in the opinion of the investigator.
- Subject must be willing to follow instructions for wound care provided by investigator and refrain from picking at the treatment device, applying topical medications to the wound, and swimming or soaking in a tub until BandGrip or the sutures are removed.
- Subject agrees to return for follow-up evaluations.
- Subject (or guardian) is able to comprehend and give informed consent for participation in this study.
Who cannot join
- Significant multiple trauma (merely multiple wounds are allowed).
- The wound involves a lower limb with critical limb ischemia.
- Concurrent acute infection requiring intravenous or oral antibiotics.
- Bleeding, coagulation and or clotting disorders.
- Subject is on dialysis.
- Inflammatory and or allergic diseases or conditions of the skin: for example, psoriasis, eczema or dermatitis.
Show all 20Show fewer
- History of drug abuse.
- Chronic use of oral steroids or immunosuppressants.
- Known personal or family history of keloid or hypertrophic scarring.
- History of abnormal wound healing.
- Burst stellate lacerations due to a crush or hard blow.
- Animal or human bite or scratch.
- Wound is in the head, hands or feet or in a high skin tension area or across an area of increased skin tension on a joint.
- Investigator objects to a patient's involvement in the study protocol.
- Known allergy to components to BandGrip or suture material.
- Known cognitive or psychiatric disorder.
- 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.
- Puncture wound.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Irvine
Irvine, California, 92868
John Fox, MD
About this study
an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture
Read the detailed description
Up to 45 subjects at up to 2 study sites who present to the ER for treatment of a skin laceration will be consented and randomized to treatment with suture or BandGrip. Subjects will be followed for 30 days post treatment to assess cosmetic quality of wound healing, evidence of adverse events related to closure method, and speed and completeness of wound closure and removal of closure devices.
- Conditions
- Laceration of Skin
- Being tested
- BandGrip, Suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BandGripDevice
Topical skin closure device
SutureDevice
Wound closure
| Study group | Role | What they receive |
|---|---|---|
| BandGrip | Experimental | Topical skin closure device Receives: Device: BandGrip |
| Standard Suture | Active comparator | Standard sutures will be used for wound closure Receives: Device: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure
defined as continuous approximation of skin margins without need for reintervention .
Measured: 30 days post treatment
Secondary outcomes (8)
Wound comesis
a 100mm visual analog scale (with 100 representing complete satisfaction with comesis) assessing wound cosmesis using the Comesis Visual Analog Scale.
Measured: 10 and 30 days post closure
Pain/discomfort
The subject will complete a 100mm visual analog scale with 100 representing worst pain level.
Measured: index procedure and 10 days post closure
Infection
incidence of clinical infection requiring antibiotic treatment.
Measured: 10 and 30 days post closure
Subject satisfaction
subjects will complete a 100mm VAS (with 100 representing complete satisfaction) to evaluate their overall assessment of their scar,
Measured: 30 days post closure
Physician satisfaction
a 100mm VAS ( with 100mm representing complete satisfaction) to evaluate the overall ease of wound closure.
Measured: index procedure
Time to wound closure and device removal
Time to closure and removal of closure device
Measured: index procedure and 10 days post wound closure
Subject Satisfaction
indication of subject preference for method of sound closure
Measured: 30 days post closure
Wound Evaluation
assessment of the quality of wound healing by the physician.
Measured: 10 and 30 days post wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start15 Jul 2018
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laceration of SkinStudies 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
- Model description
- 2:1 randomization
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BandGrip
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Donohoe, Study director, BandGrip
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628690
- Sponsor's protocol ID
- Protocol: ERM-001, Version 01
- Status last verified
- Jul 2019
- First submitted
- 18 Jul 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
- ClinicalTrials.gov ID
- NCT03628690
- Acronym / sponsor ID
- Protocol: ERM-001, Version 01
- Conditions
- Laceration of Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- BandGripIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture
Detailed description
Up to 45 subjects at up to 2 study sites who present to the ER for treatment of a skin laceration will be consented and randomized to treatment with suture or BandGrip. Subjects will be followed for 30 days post treatment to assess cosmetic quality of wound healing, evidence of adverse events related to closure method, and speed and completeness of wound closure and removal of closure devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 randomization
| Arm | Type | Receives |
|---|---|---|
| BandGrip | Experimental | Device: BandGripTopical skin closure device |
| Standard Suture | Active comparator | Device: SutureStandard sutures will be used for wound closure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male/Female age 18-65.
- Subject presents to emergency room with at least one skin laceration that is assessed as requiring a suture closure on the trunk or extremities (excluding hands and feet).
- The length of the laceration is less than or equal to 1.5 inches.
- Subject is otherwise in good general health in the opinion of the investigator.
- Subject must be willing to follow instructions for wound care provided by investigator and refrain from picking at the treatment device, applying topical medications to the wound, and swimming or soaking in a tub until BandGrip or the sutures are removed.
Key exclusion criteria (20 listed)
- Significant multiple trauma (merely multiple wounds are allowed).
- The wound involves a lower limb with critical limb ischemia.
- Concurrent acute infection requiring intravenous or oral antibiotics.
- Bleeding, coagulation and or clotting disorders.
- Subject is on dialysis.
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 |
|---|---|---|
| BandGripTopical skin closure device | Device | BandGrip |
| SutureWound closure | Device | Standard Suture |
Primary outcome
Complete wound closure
Time frame: 30 days post treatment
defined as continuous approximation of skin margins without need for reintervention .
8 secondary outcomes
Wound comesis
Time frame: 10 and 30 days post closure
Pain/discomfort
Time frame: index procedure and 10 days post closure
Infection
Time frame: 10 and 30 days post closure
Subject satisfaction
Time frame: 30 days post closure
Physician satisfaction
Time frame: index procedure
Time to wound closure and device removal
Time frame: index procedure and 10 days post wound closure
Subject Satisfaction
Time frame: 30 days post closure
Wound Evaluation
Time frame: 10 and 30 days post wound closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Dennis Donohoe study director
BandGrip
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BandGrip and Suture in people with Laceration of Skin, run by BandGrip at 1 site 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 20 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: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis J Donohoe, MD (215-499-4458, ddonohoeconsult@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound closure (time frame: 30 days post treatment). 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 10 Jul 2019.