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

NCT04122859 | Unknown

• 1 other identifier: 012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Laceration of Skin

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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.

  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 4 Surgical Skin Closure Device and the standard of care closure suturing

  Intra operative

Secondary Outcomes (4)

• Difference in Wound Evaluation Score (WES)

  10 days and 30 days post laceration repair

• Satisfaction of Rate of Wound Healing of Laceration Repair:satisfaction rating

  30 days post laceration repair

• Pain Level for Wound Healing of Laceration Repair: visual analog scale (VAS)

  Day 0 and 10 days post laceration repair

• Safety by Adverse Events reported that relate to the study device

  Intra operative through the end of the study at 30 days post laceration repair

Study Arms (2)

Zip Skin Closure Device

ACTIVE COMPARATOR

The device is a class IIa device as per Annex II of the MDD 93/42EEC, as amended by Directive 2007/47/EEC. A CE-mark was affixed in 2014. The Zip device adheres to the skin adjacent to an incision or laceration by use of pressure-sensitive skin adhesives. A combination of acrylic and hydrocolloid adhesives is used to provide a skin-friendly environment while providing the necessary tack to maintain skin adhesion during a maximum wear time of 14 days. In addition to the pressure-sensitive adhesives, the device's closure and force distribution components are made up of polyurethane monofilm, polyethylene tape, polyester and nylon.

Device: Zip Skin Closure Device

Standard of Care Sutures

ACTIVE COMPARATOR

Conventional sutures used for laceration repair

Device: Zip Skin Closure Device

Interventions

Zip Skin Closure Device 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.

Standard of Care Sutures; Zip Skin Closure Device

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between 4 to 14 years of age at the time of laceration repair.
• Require suture closure as standard of care for simple straight wounds on trunk or extremities up to 4 cm long.
• Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
• Subject and legal representative(s) are willing and able to comply with the investigational device removal and meet the follow up visit requirements.
• Subject and legal representative(s) have been informed of the nature, the scope and the relevance of the study.
• Subject and legal representative(s) 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.
• 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 enrollment.

Sponsors & Collaborators

• ZipLine Medical Inc.: lead

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

RECRUITING

Study Officials

• Uri Balla, MD

  Kaplan Medical Center, Eehovot Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Storne

CONTACT

408.684.0747; estorne@ziplinemedical.com

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 10, 2019
• Study Start: November 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 31, 2020
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)