A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics
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|ClinicalTrials.gov Identifier: NCT03199456|
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : December 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Laceration||Device: Zip 4 surgical skin closure device Device: Standard of Care sutures||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Accident and Emergency Department|
|Actual Study Start Date :||June 16, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Zip 4 Surgical Skin Closure Device group
The subjects randomised to this arm will be treated with the Zip device for 10 days (+/-2) days.
Device: Zip 4 surgical skin closure 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.
Active Comparator: Standard of Care sutures group
The subjects randomised to this arm will be treated with standard of care sutures for 10 days (+/- 2 days).
Device: Standard of Care sutures
Standard of Care sutures according to the hospitals current clinical praxis.
- 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 4 Surgical Skin Closure Device and the standard of care closure suturing.
- Objective evaluation on photographs using Wound Evaluation Score (WES) [ Time Frame: 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 4 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 [ Time Frame: Day 30 (+/- 2 days) ]Rate of wound healing satisfaction in subject at 30 days post-treatment when comparing Zip 4 Surgical Skin Closure Device versus Standard of Care closure suturing. The endpoint will utilize a questionnaire for the subject to fill out.
- Visual Analog Scale (VAS) for pain [ Time Frame: 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.
- Incidence and severity of Adverse Events (AEs) [ Time Frame: 30 days (+/-2 days) ]The incidence and severity of adverse events associated with the Zip 4 Surgical Skin Closure Device and Standard of Care closure sutures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199456
|Contact: Eric Storne||+1 650 464 email@example.com|
|Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset||Recruiting|
|Stockholm, Sweden, 171 76|
|Contact: Pia Malmquist, M.D. +46 (0) 700 028 392 firstname.lastname@example.org|
|Principal Investigator:||Pia Malmquist, M.D.||Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset, 171 76 Stockholm, Sweden|