A Skin Stretching Wound Closure System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01069614
First received: February 7, 2010
Last updated: February 16, 2010
Last verified: February 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Safety and efficacy of wound closure [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hard to close wounds

Exclusion Criteria:

  • Non-cooperative patients
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Moris Topaz, MD, PhD, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01069614     History of Changes
Other Study ID Numbers: HYMC-09
Study First Received: February 7, 2010
Last Updated: February 16, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Equipment and supplies

ClinicalTrials.gov processed this record on October 23, 2014