Laceration
Conditions
Brief 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. 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.
Interventions
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.
DEVICEStandard of Care sutures
Standard of Care sutures according to the hospitals current clinical praxis.
Sponsors
ZipLine Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Between 4 and above at the time of laceration repair. 2. Require suture closure as standard of care for simple straight wounds on trunk, extremities or face. 3. Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers. 4. 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. 5. Subject and legal representative(s) (if a pediatric subject) have been informed of the nature, the scope and the relevance of the study. 6. Subject and legal representative(s) (if a pediatric subject) have voluntarily agreed to participation and have duly signed the Informed Consent Form.
Exclusion criteria
1. Known personal or familial history of scar hypertrophy. 2. Known or suspected allergies or hypersensitivity to non-latex skin adhesives. 3. Atrophic skin deemed clinically prone to blistering. 4. Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions (dirty wounds). 5. Wounds that require deep dermal closure using sutures. 6. Known or suspected mental problems and/or aggressiveness that indicates that the subject might try to remove the device during the treatment period. 7. Ongoing treatment with cytostatic. 8. Known or suspected diagnosis of severe anorexia. 9. Participating in any other clinical investigation. 10. Known health condition that would affect healing in the opinion of the investigator. 11. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for pain | Day 0 and Day 10 (+/- 2 days) | The level of pain in connection to device application and removal measured by a visual analog scale (VAS) 0-100 mm. |
| Objective evaluation on photographs using Wound Evaluation Score (WES) | Day 0, Day 10 (+/- 2 days), Day 30 (+/- 2 days) | 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). |
| Subject satisfaction | Day 30 (+/- 2 days) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of Adverse Events (AEs) | 30 days (+/-2 days) | The incidence and severity of adverse events associated with the Zip Surgical Skin Closure Device and Standard of Care closure sutures. |
Countries
Sweden
Outcome results
None listed