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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zip surgical skin closure device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events (AEs) | The incidence and severity of adverse events associated with the Zip Surgical Skin Closure Device and Standard of Care closure sutures. | 30 days (+/-2 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pia Malmquist, M.D. | Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset, 171 76 Stockholm, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Funktionsområde Akut Huddinge, Akutmottagningen Huddinge, Karolinska Universitetssjukhuset | Huddinge | 141 86 | Sweden | |||
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Standard of Care sutures | Device | Standard of Care sutures according to the hospitals current clinical praxis. |
|
| 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. | 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. | Day 0 and Day 10 (+/- 2 days) |
| Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset |
| Stockholm |
| 171 76 |
| Sweden |