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A Skin Stretching Wound Closure System

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069614
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
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.
Information provided by:
Hillel Yaffe Medical Center
  Purpose
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 Intervention Phase
Wounds Injuries Device: TopClosure 3S System Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Safety and efficacy of wound closure

Estimated Enrollment: 30
Arms Assigned Interventions
Experimental: Skin stretching device
Skin stretching device
Device: TopClosure 3S System

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: February 7, 2010
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
Last Verified: February 2010

Keywords provided by Hillel Yaffe Medical Center:
Equipment and supplies