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

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.

Study Overview

• Status: Completed
• Conditions: Laceration
• Intervention / Treatment: Device: Zip surgical skin closure device; Device: Standard of Care sutures

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 141 86
    • Funktionsområde Akut Huddinge, Akutmottagningen Huddinge, Karolinska Universitetssjukhuset
  • Stockholm, Sweden, 171 76
    • Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zip 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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)

Other Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: ZipLine Medical Inc.
• Investigators: Principal Investigator: Pia Malmquist, M.D., Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset, 171 76 Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): July 25, 2018
• Study Completion (Actual): August 24, 2018

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: Zip-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes