Clinical trial NCT04122859: Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department
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 Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laceration of Skin
Keywords: Pediatrics
Lead sponsor: ZipLine Medical Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair. The investigation population will consist of 30 pediatric subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the Standard of Care sutures group.
Primary purpose: TREATMENT

Brief summary: A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair. The investigation population will consist of 30 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the Standard of Care sutures group.

Detailed description: The commercial use of the Zip device has demonstrated applicability and acceptance in many medical specialties, including laceration closure in the Emergency Department setting. However, while clinical studies have demonstrated quantitative performance benefits of the device in orthopedic, dermatology, cardiac and cardiology specialties, no quantitative studies have been conducted in the Emergency Department setting with the device with which emergency medicine physicians may make quantitative, informed treatment choices. The Sponsor (ZipLine Medical) and the study doctor (investigator) have furthermore identified the pediatric patient population presenting for laceration repair in the Emergency Department as a group that may uniquely benefit from the use of the Zip device.

Standard care for wounds of this type require cleaning the wound, anesthetizing the wound and closing the wound with sutures that typically require subsequent removal at a later date. The Zip device is non-invasive and therefore requires no injected anesthesia or sedation for wound closure. In addition, the referenced clinical studies have demonstrated at least a 3 times speed advantage over sutures. The Zip device ease of use and consistency of outcomes enables less skilled or experienced caregivers to perform fast, efficient and excellent wound closure, which can improve department and staff efficiency, patient throughput and overall patient satisfaction. Finally, the Zip device may be removed by the patient or parent at home, eliminating a return-to-clinic visit for removal.

ZipLine Medical believes that the demonstrated benefits of the Zip device will be more pronounced with the specified pediatric population due to reduced procedure time, elimination of injected anesthesia and elimination of a return visit for suture removal. ZipLine Medical believes that this will reduce fear and anxiety in pediatric patients. Furthermore, ZipLine Medical believes that the Zip device can improve Emergency Department efficiency and patient throughput, reduce overall healthcare cost and improve overall patient (and parent) satisfaction.

Eligibility criteria: Inclusion Criteria:

1. Between 4 to 14 years of age at the time of laceration repair.
2. Require suture closure as standard of care for simple straight wounds on trunk or extremities up to 4 cm long.
3. Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
4. Subject and legal representative(s) are willing and able to comply with the investigational device removal and meet the follow up visit requirements.
5. Subject and legal representative(s) have been informed of the nature, the scope and the relevance of the study.
6. Subject and legal representative(s) 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. Participating in any other clinical investigation.
8. Known health condition that would affect healing in the opinion of the investigator.
9. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrollment.

Primary outcomes:
measure: Mean difference in time to wound closure of the Zip 4 Surgical Skin Closure Device in comparison to conventional sutures used in a pediatric population presenting for laceration repair.
timeFrame: Intra operative
Secondary outcomes:
measure: Difference in Wound Evaluation Score (WES)
timeFrame: 10 days and 30 days post laceration repair
measure: Satisfaction of Rate of Wound Healing of Laceration Repair:satisfaction rating
timeFrame: 30 days post laceration repair
measure: Pain Level for Wound Healing of Laceration Repair: visual analog scale (VAS)
timeFrame: Day 0 and 10 days post laceration repair
measure: Safety by Adverse Events reported that relate to the study device
timeFrame: Intra operative through the end of the study at 30 days post laceration repair
Other outcomes:
Locations:
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
Study officials:
affiliation: Kaplan Medical Center, Eehovot Israel
name: Uri Balla, MD
role: PRINCIPAL_INVESTIGATOR
References: