Back to resultsA Skin Stretching Wound Closure System
Primary Purpose
Wounds, Injuries
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
TopClosure 3S System
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring Equipment and supplies
Eligibility Criteria
Inclusion Criteria:
- Hard to close wounds
Exclusion Criteria:
- Non-cooperative patients
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Skin stretching device
Arm Description
Skin stretching device
Outcomes
Primary Outcome Measures
Safety and efficacy of wound closure
Secondary Outcome Measures
Full Information
NCT ID
NCT01069614
First Posted
February 7, 2010
Last Updated
February 16, 2010
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01069614
Brief Title
A Skin Stretching Wound Closure System
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
5. Study Description
Brief Summary
A skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. The device may be used in non-invasive and invasive applications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds, Injuries
Keywords
Equipment and supplies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Skin stretching device
Arm Type
Experimental
Arm Description
Skin stretching device
Intervention Type
Device
Intervention Name(s)
TopClosure 3S System
Primary Outcome Measure Information:
Title
Safety and efficacy of wound closure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hard to close wounds
Exclusion Criteria:
Non-cooperative patients
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moris Topaz, MD, PhD
Phone
972-4-630-4689
Email
mtopazmd@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
A Skin Stretching Wound Closure System
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