Status:
UNKNOWN
Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department
Lead Sponsor:
ZipLine Medical Inc.
Conditions:
Laceration of Skin
Eligibility:
All Genders
4-14 years
Phase:
NA
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 fulfi...
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 clinica...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04122859
Start Date
November 1 2018
End Date
July 31 2020
Last Update
October 10 2019
Active Locations (1)
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1
Kaplan Medical Center
Rehovot, Israel