Back to resultsA Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults
Primary Purpose
Laceration
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Zip surgical skin closure device
Standard of Care sutures
Sponsored by
About this trial
This is an interventional treatment trial for Laceration
Eligibility Criteria
Inclusion Criteria:
- Between 4 and above at the time of laceration repair.
- Require suture closure as standard of care for simple straight wounds on trunk, extremities or face.
- Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
- Subject and legal representative(s) (if a pediatric subject) are willing and able to comply with the investigational device removal and meet the follow up requirements.
- Subject and legal representative(s) (if a pediatric subject) have been informed of the nature, the scope and the relevance of the study.
- Subject and legal representative(s) (if a pediatric subject) have voluntarily agreed to participation and have duly signed the Informed Consent Form.
Exclusion Criteria:
- 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.
- Ongoing treatment with cytostatic.
- Known or suspected diagnosis of severe anorexia.
- 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 enrolment.
Sites / Locations
- Funktionsområde Akut Huddinge, Akutmottagningen Huddinge, Karolinska Universitetssjukhuset
- Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Zip Surgical Skin Closure Device group
Standard of Care sutures group
Arm Description
The subjects randomised to this arm will be treated with the Zip device for 10 days (+/-2) days.
The subjects randomised to this arm will be treated with standard of care sutures for 10 days (+/- 2 days).
Outcomes
Primary Outcome Measures
Treatment time
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 Surgical Skin Closure Device and the standard of care closure suturing.
Secondary Outcome Measures
Objective evaluation on photographs using Wound Evaluation Score (WES)
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 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).
Subject satisfaction
Rate of wound healing satisfaction in subject at 30 days post-treatment when comparing Zip Surgical Skin Closure Device versus Standard of Care closure suturing. The endpoint will utilize a questionnaire for the subject to fill out.
Visual Analog Scale (VAS) for pain
The level of pain in connection to device application and removal measured by a visual analog scale (VAS) 0-100 mm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03199456
Brief Title
A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults
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 and Adults in an Accident and Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
August 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZipLine Medical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Zip-009 clinical investigation will enroll 26 paediatric and adult 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 device compared to conventional sutures. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zip Surgical Skin Closure Device group
Arm Type
Experimental
Arm Description
The subjects randomised to this arm will be treated with the Zip device for 10 days (+/-2) days.
Arm Title
Standard of Care sutures group
Arm Type
Active Comparator
Arm Description
The subjects randomised to this arm will be treated with standard of care sutures for 10 days (+/- 2 days).
Intervention Type
Device
Intervention Name(s)
Zip surgical skin closure device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard of Care sutures
Intervention Description
Standard of Care sutures according to the hospitals current clinical praxis.
Primary Outcome Measure Information:
Title
Treatment time
Description
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 Surgical Skin Closure Device and the standard of care closure suturing.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Objective evaluation on photographs using Wound Evaluation Score (WES)
Description
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 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).
Time Frame
Day 0, Day 10 (+/- 2 days), Day 30 (+/- 2 days)
Title
Subject satisfaction
Description
Rate of wound healing satisfaction in subject at 30 days post-treatment when comparing Zip Surgical Skin Closure Device versus Standard of Care closure suturing. The endpoint will utilize a questionnaire for the subject to fill out.
Time Frame
Day 30 (+/- 2 days)
Title
Visual Analog Scale (VAS) for pain
Description
The level of pain in connection to device application and removal measured by a visual analog scale (VAS) 0-100 mm.
Time Frame
Day 0 and Day 10 (+/- 2 days)
Other Pre-specified Outcome Measures:
Title
Incidence and severity of Adverse Events (AEs)
Description
The incidence and severity of adverse events associated with the Zip Surgical Skin Closure Device and Standard of Care closure sutures.
Time Frame
30 days (+/-2 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 4 and above at the time of laceration repair.
Require suture closure as standard of care for simple straight wounds on trunk, extremities or face.
Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
Subject and legal representative(s) (if a pediatric subject) are willing and able to comply with the investigational device removal and meet the follow up requirements.
Subject and legal representative(s) (if a pediatric subject) have been informed of the nature, the scope and the relevance of the study.
Subject and legal representative(s) (if a pediatric subject) have voluntarily agreed to participation and have duly signed the Informed Consent Form.
Exclusion Criteria:
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.
Ongoing treatment with cytostatic.
Known or suspected diagnosis of severe anorexia.
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 enrolment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Malmquist, M.D.
Organizational Affiliation
Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset, 171 76 Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Funktionsområde Akut Huddinge, Akutmottagningen Huddinge, Karolinska Universitetssjukhuset
City
Huddinge
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Funktionsområde Akutsjukvård Barn Solna, Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults
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