Clinical trial NCT03199456: A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults
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 and Adults in an Accident and Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laceration
Lead sponsor: ZipLine Medical Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 26
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment time
timeFrame: Day 0
Secondary outcomes:
measure: Objective evaluation on photographs using Wound Evaluation Score (WES)
timeFrame: Day 0, Day 10 (+/- 2 days), Day 30 (+/- 2 days)
measure: Subject satisfaction
timeFrame: Day 30 (+/- 2 days)
measure: Visual Analog Scale (VAS) for pain
timeFrame: Day 0 and Day 10 (+/- 2 days)
Other outcomes:
measure: Incidence and severity of Adverse Events (AEs)
timeFrame: 30 days (+/-2 days)
Locations:
city: Huddinge
country: Sweden
facility: Funktionsområde Akut Huddinge, Akutmottagningen Huddinge, Karolinska Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset
Study officials:
affiliation: Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset, 171 76 Stockholm, Sweden
name: Pia Malmquist, M.D.
role: PRINCIPAL_INVESTIGATOR
References: