Laceration of SkinZIPPEDNCT04122859
Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department
A study testing Zip Skin Closure Device in people with Laceration of Skin, run by ZipLine Medical Inc. at 1 site in Israel.
Trial summary
A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair. The investigation population will consist of 30 subjects fulfilling the eligibility criteria for the clinical investigation. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Laceration of Skin
- What is being tested?
- Zip Skin Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2018to 31 Jul 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 4 to 14 years of age at the time of laceration repair.
- Require suture closure as standard of care for simple straight wounds on trunk or extremities up to 4 cm long.
- Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
- Subject and legal representative(s) are willing and able to comply with the investigational device removal and meet the follow up visit requirements.
- Subject and legal representative(s) have been informed of the nature, the scope and the relevance of the study.
- Subject and legal representative(s) have voluntarily agreed to participation and have duly signed the Informed Consent Form.
Who cannot join
- Known personal or familial history of scar hypertrophy.
- Known or suspected allergies or hypersensitivity to non-latex skin adhesives.
- Atrophic skin deemed clinically prone to blistering.
- Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions ("dirty wounds").
- Wounds that require deep dermal closure using sutures.
- Known or suspected mental problems and/or aggressiveness that indicates that the subject might try to remove the device during the treatment period.
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- Participating in any other clinical investigation.
- Known health condition that would affect healing in the opinion of the investigator.
- Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrollment.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot
Uri Balla, MD, +972-52-2326141, Uribal@clalit.org.il
About this study
Official title: A Randomized, Controlled, Post-market Clinical Investigation to Evaluate Zip Surgical Skin Closure Device in Comparison of Using Standard of Care Sutures for Laceration Repair in Pediatrics in an Emergency Department
A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair. The investigation population will consist of 30 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the Standard of Care sutures group.
Read the detailed description
The commercial use of the Zip device has demonstrated applicability and acceptance in many medical specialties, including laceration closure in the Emergency Department setting. However, while clinical studies have demonstrated quantitative performance benefits of the device in orthopedic, dermatology, cardiac and cardiology specialties, no quantitative studies have been conducted in the Emergency Department setting with the device with which emergency medicine physicians may make quantitative, informed treatment choices. The Sponsor (ZipLine Medical) and the study doctor (investigator) have furthermore identified the pediatric patient population presenting for laceration repair in the Emergency Department as a group that may uniquely benefit from the use of the Zip device.
Standard care for wounds of this type require cleaning the wound, anesthetizing the wound and closing the wound with sutures that typically require subsequent removal at a later date. The Zip device is non-invasive and therefore requires no injected anesthesia or sedation for wound closure. In addition, the referenced clinical studies have demonstrated at least a 3 times speed advantage over sutures. The Zip device ease of use and consistency of outcomes enables less skilled or experienced caregivers to perform fast, efficient and excellent wound closure, which can improve department and staff efficiency, patient throughput and overall patient satisfaction. Finally, the Zip device may be removed by the patient or parent at home, eliminating a return-to-clinic visit for removal.
ZipLine Medical believes that the demonstrated benefits of the Zip device will be more pronounced with the specified pediatric population due to reduced procedure time, elimination of injected anesthesia and elimination of a return visit for suture removal. ZipLine Medical believes that this will reduce fear and anxiety in pediatric patients. Furthermore, ZipLine Medical believes that the Zip device can improve Emergency Department efficiency and patient throughput, reduce overall healthcare cost and improve overall patient (and parent) satisfaction.
- Conditions
- Laceration of Skin
- Being tested
- Zip Skin Closure Device
- Keywords
- Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zip Skin Closure DeviceDevice
The device is a CE-marked, single use, sterile medical device that is designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic outcome. It adheres to the skin adjacent to an incision or laceration by use of pressure-sensitive skin adhesives.
| Study group | Role | What they receive |
|---|---|---|
| Zip Skin Closure Device | Active comparator | The device is a class IIa device as per Annex II of the MDD 93/42EEC, as amended by Directive 2007/47/EEC. A CE-mark was affixed in 2014. The Zip device adheres to the skin adjacent to an incision or laceration by use of pressure-sensitive skin adhesives. A combination of acrylic and hydrocolloid adhesives is used to provide a skin-friendly environment while providing the necessary tack to maintain skin adhesion during a maximum wear time of 14 days. In addition to the pressure-sensitive adhesives, the device's closure and force distribution components are made up of polyurethane monofilm, polyethylene tape, polyester and nylon. Receives: Device: Zip Skin Closure Device |
| Standard of Care Sutures | Active comparator | Conventional sutures used for laceration repair Receives: Device: Zip Skin Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in time to wound closure of the Zip 4 Surgical Skin Closure Device in comparison to conventional sutures used in a pediatric population presenting for laceration repair.
These include total treatment time and duration of period starting from the preparation of procedure until protective wound dressing is applied, and including whether or not anesthesia and/or sedation was used when comparing the Zip 4 Surgical Skin Closure Device and the standard of care closure suturing
Measured: Intra operative
Secondary outcomes (4)
Difference in Wound Evaluation Score (WES)
A Wound Evaluation Score will be documented by an independent reviewer of photos taken at Day 0 and compared to 10 Day and 30 Day to evaluate the satisfaction and outcomes of the Zip 4 Surgical Skin Closure Device in comparison to conventional sutures used in a pediatric population presenting for laceration repair. The WES evaluates six clinical variables including incision edges, contour irregularity, width, edge inversion, inflammation and overall cosmesis. A score of 6 is considered optimal, while a score of < or =5 suboptimal.
Measured: 10 days and 30 days post laceration repair
Satisfaction of Rate of Wound Healing of Laceration Repair:satisfaction rating
Parents of patients will document the rate of wound healing satisfaction in subject post-treatment. The satisfaction rating for the Zip 4 Surgical Skin Closure Device will be compared to conventional sutures used in a pediatric population for laceration repair. The questionnaire will contain questions where the parent either will mark the most correct answer or rate on a line between 0 (Very Satisfied) to 100 (Very Dissatisfied) mm.
Measured: 30 days post laceration repair
Pain Level for Wound Healing of Laceration Repair: visual analog scale (VAS)
Parents of patients will document the level of pain the patient experiences in connection to the Zip 4 Surgical Skin Closure Device and conventional sutures application and removal used in a pediatric population for laceration repair by a visual analog scale (VAS) 0 (No Pain) -100 (Worst Pain) mm
Measured: Day 0 and 10 days post laceration repair
Safety by Adverse Events reported that relate to the study device
The incidence and severity of adverse events associated with the Zip 4 Surgical Skin Closure Device and Standard of Care closure sutures.
Measured: Intra operative through the end of the study at 30 days post laceration repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Nov 2018
- Primary completion1 Jul 2020 (estimated)
- Study completion31 Jul 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
- A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair. The investigation population will consist of 30 pediatric subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the Standard of Care sutures group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZipLine Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uri Balla, MD, Principal investigator, Kaplan Medical Center, Eehovot Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122859
- Sponsor's protocol ID
- 012
- Acronym
- ZIPPED
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Post-market Clinical Investigation to Evaluate Zip Surgical Skin Closure Device in Comparison of Using Standard of Care Sutures for Laceration Repair in Pediatrics in an Emergency Department
- ClinicalTrials.gov ID
- NCT04122859
- Acronym / sponsor ID
- ZIPPED / 012
- Conditions
- Laceration of Skin
- Keywords
- Pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ZipLine Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 10 Oct 2019 (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.
A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair. The investigation population will consist of 30 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the Standard of Care sutures group.
Detailed description
The commercial use of the Zip device has demonstrated applicability and acceptance in many medical specialties, including laceration closure in the Emergency Department setting. However, while clinical studies have demonstrated quantitative performance benefits of the device in orthopedic, dermatology, cardiac and cardiology specialties, no quantitative studies have been conducted in the Emergency Department setting with the device with which emergency medicine physicians may make quantitative, informed treatment choices. The Sponsor (ZipLine Medical) and the study doctor (investigator) have furthermore identified the pediatric patient population presenting for laceration repair in the Emergency Department as a group that may uniquely benefit from the use of the Zip device.
Standard care for wounds of this type require cleaning the wound, anesthetizing the wound and closing the wound with sutures that typically require subsequent removal at a later date. The Zip device is non-invasive and therefore requires no injected anesthesia or sedation for wound closure. In addition, the referenced clinical studies have demonstrated at least a 3 times speed advantage over sutures. The Zip device ease of use and consistency of outcomes enables less skilled or experienced caregivers to perform fast, efficient and excellent wound closure, which can improve department and staff efficiency, patient throughput and overall patient satisfaction. Finally, the Zip device may be removed by the patient or parent at home, eliminating a return-to-clinic visit for removal.
ZipLine Medical believes that the demonstrated benefits of the Zip device will be more pronounced with the specified pediatric population due to reduced procedure time, elimination of injected anesthesia and elimination of a return visit for suture removal. ZipLine Medical believes that this will reduce fear and anxiety in pediatric patients. Furthermore, ZipLine Medical believes that the Zip device can improve Emergency Department efficiency and patient throughput, reduce overall healthcare cost and improve overall patient (and parent) satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair. The investigation population will consist of 30 pediatric subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the Standard of Care sutures group.
| Arm | Type | Receives |
|---|---|---|
| Zip Skin Closure Device | Active comparator | Device: Zip Skin Closure DeviceThe device is a class IIa device as per Annex II of the MDD 93/42EEC, as amended by Directive 2007/47/EEC. A CE-mark was affixed in 2014. The Zip device adheres to the skin adjacent to an incision or laceration by use of pressure-sensitive skin adhesives. A combination of acrylic and hydrocolloid adhesives is used to provide a skin-friendly environment while providing the necessary tack to maintain skin adhesion during a maximum wear time of 14 days. In addition to the pressure-sensitive adhesives, the device's closure and force distribution components are made up of polyurethane monofilm, polyethylene tape, polyester and nylon. |
| Standard of Care Sutures | Active comparator | Device: Zip Skin Closure DeviceConventional sutures used for laceration repair |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Between 4 to 14 years of age at the time of laceration repair.
- Require suture closure as standard of care for simple straight wounds on trunk or extremities up to 4 cm long.
- Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
- Subject and legal representative(s) are willing and able to comply with the investigational device removal and meet the follow up visit requirements.
- Subject and legal representative(s) have been informed of the nature, the scope and the relevance of the study.
Key exclusion criteria (9 listed)
- Known personal or familial history of scar hypertrophy.
- Known or suspected allergies or hypersensitivity to non-latex skin adhesives.
- Atrophic skin deemed clinically prone to blistering.
- Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions ("dirty wounds").
- Wounds that require deep dermal closure using sutures.
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 |
|---|---|---|
| Zip Skin Closure DeviceThe device is a CE-marked, single use, sterile medical device that is designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic outcome. It adheres to the skin adjacent to an incision or laceration by use of pressure-sensitive skin adhesives. | Device | Standard of Care Sutures, Zip Skin Closure Device |
Primary outcome
Mean difference in time to wound closure of the Zip 4 Surgical Skin Closure Device in comparison to conventional sutures used in a pediatric population presenting for laceration repair.
Time frame: Intra operative
These include total treatment time and duration of period starting from the preparation of procedure until protective wound dressing is applied, and including whether or not anesthesia and/or sedation was used when comparing the Zip 4 Surgical Skin Closure Device and the standard of care closure suturing
4 secondary outcomes
Difference in Wound Evaluation Score (WES)
Time frame: 10 days and 30 days post laceration repair
Satisfaction of Rate of Wound Healing of Laceration Repair:satisfaction rating
Time frame: 30 days post laceration repair
Pain Level for Wound Healing of Laceration Repair: visual analog scale (VAS)
Time frame: Day 0 and 10 days post laceration repair
Safety by Adverse Events reported that relate to the study device
Time frame: Intra operative through the end of the study at 30 days post laceration repair
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 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.
Uri Balla, MD principal investigator
Kaplan Medical Center, Eehovot Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zip Skin Closure Device in people with Laceration of Skin, run by ZipLine Medical Inc. at 1 site in Israel.
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 6 inclusion and 9 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 Oct 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 Israel. 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 Eric Storne (408.684.0747, estorne@ziplinemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in time to wound closure of the Zip 4 Surgical Skin Closure Device in comparison to conventional sutures used in a pediatric population presenting for laceration repair. (time frame: Intra operative). 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 Oct 2019.