NCT04122859

Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: ZipLine Medical Inc. · Industry
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laceration of Skin

Interventions

Type	Name	Description
DEVICE	Zip Skin Closure Device	The device is a CE-marked, single use, sterile medical device that is designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic outcome. It adheres to the skin adjacent to an incision or laceration by use of pressure-sensitive skin adhesives.

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-07-01
• Completion: 2020-07-31
• First posted: 2019-10-10
• Last updated: 2019-10-10

Locations

1 site across 1 country: Israel