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

NCT03199456 | Completed FDA Device

• 1 other identifier: Zip-009
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Laceration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objective evaluation on photographs using Wound Evaluation Score (WES)

  Day 0, Day 10 (+/- 2 days), Day 30 (+/- 2 days)

• Subject satisfaction

  Day 30 (+/- 2 days)

• Visual Analog Scale (VAS) for pain

  Day 0 and Day 10 (+/- 2 days)

Other Outcomes (1)

• Incidence and severity of Adverse Events (AEs)

  30 days (+/-2 days)

Study Arms (2)

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.

Device: Zip surgical skin closure device

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).

Device: Standard of Care sutures

Interventions

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.

Zip Surgical Skin Closure Device group

Standard of Care sutures DEVICE

Standard of Care sutures according to the hospitals current clinical praxis.

Standard of Care sutures group

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 4 and above at the time of laceration repair.
• Require suture closure as standard of care for simple straight wounds on trunk, extremities or face.
• Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
• 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.
• Subject and legal representative(s) (if a pediatric subject) have been informed of the nature, the scope and the relevance of the study.
• Subject and legal representative(s) (if a pediatric subject) have voluntarily agreed to participation and have duly signed the Informed Consent Form.

You may not qualify if:

• Known personal or familial history of scar hypertrophy.
• Known or suspected allergies or hypersensitivity to non-latex skin adhesives.
• Atrophic skin deemed clinically prone to blistering.
• Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions ("dirty wounds").
• Wounds that require deep dermal closure using sutures.
• Known or suspected mental problems and/or aggressiveness that indicates that the subject might try to remove the device during the treatment period.
• Ongoing treatment with cytostatic.
• Known or suspected diagnosis of severe anorexia.
• Participating in any other clinical investigation.
• Known health condition that would affect healing in the opinion of the investigator.
• Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.

Sponsors & Collaborators

• ZipLine Medical Inc.: lead

Study Sites (2)

Funktionsområde Akut Huddinge, Akutmottagningen Huddinge, Karolinska Universitetssjukhuset

Huddinge, 141 86, Sweden

Location

Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Pia Malmquist, M.D.

  Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset, 171 76 Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 27, 2017
• Study Start: June 16, 2017
• Primary Completion: July 25, 2018
• Study Completion: August 24, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)