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Trial record 3 of 138 for:    Recruiting, Not yet recruiting, Available Studies | "Lacerations"

A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics

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ClinicalTrials.gov Identifier: NCT03199456
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
ZipLine Medical Inc.

Brief Summary:
The Zip-009 clinical investigation will enroll 26 paediatric 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 4 device compared to conventional sutures. 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. 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.

Condition or disease Intervention/treatment Phase
Laceration Device: Zip 4 surgical skin closure device Device: Standard of Care sutures Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Accident and Emergency Department
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zip 4 Surgical Skin Closure Device group
The subjects randomised to this arm will be treated with the Zip device for 10 days (+/-2) days.
Device: Zip 4 surgical skin closure device
Zip surgical skin closure device manufactured by ZipLine Medical, Inc. is a CE-marked, non-invasive, single use device that is designated to provide closure of the skin layer for lacerations or surgical incisions.

Active Comparator: Standard of Care sutures group
The subjects randomised to this arm will be treated with standard of care sutures for 10 days (+/- 2 days).
Device: Standard of Care sutures
Standard of Care sutures according to the hospitals current clinical praxis.




Primary Outcome Measures :
  1. Treatment time [ Time Frame: Day 0 ]
    The primary endpoint in this clinical investigation is the mean difference in time to wound closure, for the two treatment methods used. 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.


Secondary Outcome Measures :
  1. Objective evaluation on photographs using Wound Evaluation Score (WES) [ Time Frame: Day 0, Day 10 (+/- 2 days), Day 30 (+/- 2 days) ]
    Difference in Wound Evaluation Score at 10 days and 30 days post-treatment compare to baseline when comparing scar satisfaction and appearance of the subjects receiving Zip 4 Surgical Skin Closure Device versus Standard of Care closure suturing. The score will be based on digital photographs taken on day 0, day 10 and day 30 and made by an independent panel of blinded physician(s).

  2. Subject satisfaction [ Time Frame: Day 30 (+/- 2 days) ]
    Rate of wound healing satisfaction in subject at 30 days post-treatment when comparing Zip 4 Surgical Skin Closure Device versus Standard of Care closure suturing. The endpoint will utilize a questionnaire for the subject to fill out.

  3. Visual Analog Scale (VAS) for pain [ Time Frame: Day 0 and Day 10 (+/- 2 days) ]
    The level of pain in connection to device application and removal measured by a visual analog scale (VAS) 0-100 mm.


Other Outcome Measures:
  1. Incidence and severity of Adverse Events (AEs) [ Time Frame: 30 days (+/-2 days) ]
    The incidence and severity of adverse events associated with the Zip 4 Surgical Skin Closure Device and Standard of Care closure sutures.



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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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 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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199456


Contacts
Contact: Eric Storne +1 650 464 5073 estorne@ziplinemedical.com

Locations
Sweden
Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset Recruiting
Stockholm, Sweden, 171 76
Contact: Pia Malmquist, M.D.    +46 (0) 700 028 392    pia.malmquist@sll.se   
Sponsors and Collaborators
ZipLine Medical Inc.
Investigators
Principal Investigator: Pia Malmquist, M.D. Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset, 171 76 Stockholm, Sweden

Responsible Party: ZipLine Medical Inc.
ClinicalTrials.gov Identifier: NCT03199456     History of Changes
Other Study ID Numbers: Zip-009
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries