LacerationNCT03199456
A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults
A study testing Zip surgical skin closure device in people with Laceration, run by ZipLine Medical Inc. at 2 sites in Sweden.
Trial summary
The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Laceration
- What is being tested?
- Zip surgical skin closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesSweden
- Study dates
- 16 Jun 2017to 24 Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Between 4 and above at the time of laceration repair.
- Require suture closure as standard of care for simple straight wounds on trunk, extremities or face.
- Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
- Subject and legal representative(s) (if a pediatric subject) are willing and able to comply with the investigational device removal and meet the follow up requirements.
- Subject and legal representative(s) (if a pediatric subject) have been informed of the nature, the scope and the relevance of the study.
- Subject and legal representative(s) (if a pediatric subject) 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.
Show all 11Show fewer
- Ongoing treatment with cytostatic.
- Known or suspected diagnosis of severe anorexia.
- 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 enrolment.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Funktionsområde Akut Huddinge, Akutmottagningen Huddinge, Karolinska Universitetssjukhuset
Huddinge, 141 86
Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset
Stockholm, 171 76
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 and Adults in an Accident and Emergency Department
The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation. The investigation is designed to evaluate the time and cost savings and the satisfaction and outcomes of the Zip device compared to conventional sutures. The subjects will be randomly assigned at a 1:1 ratio to either the Zip Surgical Skin Closure Device group or the Standard of Care sutures group. The investigation consists of one screening/baseline visits at day 0 where the subject will be treated with either the Zip device or sutures, and thereafter two follow up telephone calls at day 10 and day 30. The Zip device/sutures will be removed prior the first follow up call day 10. The duration of the investigation is estimated to 5 months, including a 4-month recruitment period and 1-month follow up period.
- Conditions
- Laceration
- Being tested
- Zip surgical skin closure device, Standard of Care sutures
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zip surgical skin closure deviceDevice
Zip surgical skin closure device manufactured by ZipLine Medical, Inc. is a CE-marked, non-invasive, single use device that is designated to provide closure of the skin layer for lacerations or surgical incisions.
Standard of Care suturesDevice
Standard of Care sutures according to the hospitals current clinical praxis.
| Study group | Role | What they receive |
|---|---|---|
| Zip Surgical Skin Closure Device group | Experimental | The subjects randomised to this arm will be treated with the Zip device for 10 days (+/-2) days. Receives: Device: Zip surgical skin closure device |
| Standard of Care sutures group | Active comparator | The subjects randomised to this arm will be treated with standard of care sutures for 10 days (+/- 2 days). Receives: Device: Standard of Care sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment time
The primary endpoint in this clinical investigation is the mean difference in time to wound closure, for the two treatment methods used. 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 Surgical Skin Closure Device and the standard of care closure suturing.
Measured: Day 0
Secondary outcomes (3)
Objective evaluation on photographs using Wound Evaluation Score (WES)
Difference in Wound Evaluation Score at 10 days and 30 days post-treatment compare to baseline when comparing scar satisfaction and appearance of the subjects receiving Zip Surgical Skin Closure Device versus Standard of Care closure suturing. The score will be based on digital photographs taken on day 0, day 10 and day 30 and made by an independent panel of blinded physician(s).
Measured: Day 0, Day 10 (+/- 2 days), Day 30 (+/- 2 days)
Subject satisfaction
Rate of wound healing satisfaction in subject at 30 days post-treatment when comparing Zip Surgical Skin Closure Device versus Standard of Care closure suturing. The endpoint will utilize a questionnaire for the subject to fill out.
Measured: Day 30 (+/- 2 days)
Visual Analog Scale (VAS) for pain
The level of pain in connection to device application and removal measured by a visual analog scale (VAS) 0-100 mm.
Measured: Day 0 and Day 10 (+/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start16 Jun 2017
- Primary completion25 Jul 2018
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LacerationStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZipLine Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pia Malmquist, M.D., Principal investigator, Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset, 171 76 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199456
- Sponsor's protocol ID
- Zip-009
- Status last verified
- Sep 2018
- First submitted
- 19 Jun 2017
- Last updated
- 24 Sep 2018
- 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 24 Sep 2018. 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 and Adults in an Accident and Emergency Department
- ClinicalTrials.gov ID
- NCT03199456
- Acronym / sponsor ID
- Zip-009
- Conditions
- Laceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ZipLine Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 27 Jun 2017 (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.
The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation. The investigation is designed to evaluate the time and cost savings and the satisfaction and outcomes of the Zip device compared to conventional sutures. The subjects will be randomly assigned at a 1:1 ratio to either the Zip Surgical Skin Closure Device group or the Standard of Care sutures group. The investigation consists of one screening/baseline visits at day 0 where the subject will be treated with either the Zip device or sutures, and thereafter two follow up telephone calls at day 10 and day 30. The Zip device/sutures will be removed prior the first follow up call day 10. The duration of the investigation is estimated to 5 months, including a 4-month recruitment period and 1-month follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zip Surgical Skin Closure Device group | Experimental | Device: Zip surgical skin closure deviceThe subjects randomised to this arm will be treated with the Zip device for 10 days (+/-2) days. |
| Standard of Care sutures group | Active comparator | Device: Standard of Care suturesThe subjects randomised to this arm will be treated with standard of care sutures for 10 days (+/- 2 days). |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Between 4 and above at the time of laceration repair.
- Require suture closure as standard of care for simple straight wounds on trunk, extremities or face.
- Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
- Subject and legal representative(s) (if a pediatric subject) are willing and able to comply with the investigational device removal and meet the follow up requirements.
- Subject and legal representative(s) (if a pediatric subject) have been informed of the nature, the scope and the relevance of the study.
Key exclusion criteria (11 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 surgical skin closure deviceZip surgical skin closure device manufactured by ZipLine Medical, Inc. is a CE-marked, non-invasive, single use device that is designated to provide closure of the skin layer for lacerations or surgical incisions. | Device | Zip Surgical Skin Closure Device group |
| Standard of Care suturesStandard of Care sutures according to the hospitals current clinical praxis. | Device | Standard of Care sutures group |
Primary outcome
Treatment time
Time frame: Day 0
The primary endpoint in this clinical investigation is the mean difference in time to wound closure, for the two treatment methods used. 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 Surgical Skin Closure Device and the standard of care closure suturing.
3 secondary outcomes
Objective evaluation on photographs using Wound Evaluation Score (WES)
Time frame: Day 0, Day 10 (+/- 2 days), Day 30 (+/- 2 days)
Subject satisfaction
Time frame: Day 30 (+/- 2 days)
Visual Analog Scale (VAS) for pain
Time frame: Day 0 and Day 10 (+/- 2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Laceration
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Not yet recruitingPhase 4
Cooling Eyedrops for Dry Eye
Dry Eye
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
Not yet recruiting
A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)
CerebroSpinal Fluid (CSF) Leak, Dural Tear
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.
Pia Malmquist, M.D. principal investigator
Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset, 171 76 Stockholm, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zip surgical skin closure device in people with Laceration, run by ZipLine Medical Inc. at 2 sites in Sweden.
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 11 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 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment time (time frame: Day 0). 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 24 Sep 2018.