A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults

Not Applicable

Completed

• Conditions: Laceration
• Interventions: Device: Zip surgical skin closure device; Device: Standard of Care sutures

• Registration Number: NCT03199456
• Lead Sponsor: ZipLine Medical Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-16
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-27
• Primary Completion: 2018-07-25
• Study Completion: 2018-08-24
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zip Surgical Skin Closure Device group	Zip surgical skin closure device	The subjects randomised to this arm will be treated with the Zip device for 10 days (+/-2) days.
Standard of Care sutures group	Standard of Care sutures	The subjects randomised to this arm will be treated with standard of care sutures for 10 days (+/- 2 days).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.

Trial Locations

Locations (2)

Funktionsområde Akut Huddinge, Akutmottagningen Huddinge, Karolinska Universitetssjukhuset; 🇸🇪 Huddinge, Sweden

Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden