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A Skin Stretching Wound Closure System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01069614
Recruitment Status : Unknown
Verified February 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 17, 2010
Last Update Posted : February 17, 2010
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Wounds Injuries Device: TopClosure 3S System Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Skin stretching device
Skin stretching device
Device: TopClosure 3S System


Outcome Measures

Primary Outcome Measures :
  1. Safety and efficacy of wound closure

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hard to close wounds

Exclusion Criteria:

  • Non-cooperative patients
Contacts and Locations

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): NCT01069614


Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Moris Topaz, MD, PhD    972-4-630-4689    mtopazmd@yahoo.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
More Information

Responsible Party: Moris Topaz, MD, PhD, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01069614     History of Changes
Other Study ID Numbers: HYMC-09
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: February 2010

Keywords provided by Hillel Yaffe Medical Center:
Equipment and supplies