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Fasciocutaneous Flaps for Leg Defects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278836
First Posted: January 19, 2011
Last Update Posted: January 27, 2011
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:
Isfahan University of Medical Sciences
  Purpose
The purpose of this study is to determine the effects of fasciocutaneous flaps for leg defects.

Condition Intervention Phase
Limb Defects Procedure: fasciocutaneous flap Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Fasciocutaneous Flaps for Treatment of Leg Defects

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • necrosis [ Time Frame: at three years after surgery ]

Secondary Outcome Measures:
  • venous congestion [ Time Frame: at three years after surgery ]

Enrollment: 23
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
fascio-cutaneous flap
flaps which include skin, subcutaneous tissue, and the underlying fascia.
Procedure: fasciocutaneous flap
flaps which include skin, subcutaneous tissue, and the underlying fascia.

Detailed Description:
The fasciocutaneous flaps are tissue flaps which include skin, subcutaneous tissue, and the underlying fascia. Including the deep fascia with its prefascial and subfascial plexus enhances the circulation of these flaps. The investigators determined long-term outcomes of fasciocutaneous flap reconstruction in patients with lower limb defects.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with leg defects

Exclusion Criteria:

  • patients with underlying diseases
  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): NCT01278836


Locations
Iran, Islamic Republic of
Kashani University Hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: hamidreza shemshaki, MD MD,research comittee
  More Information

Additional Information:
Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01278836     History of Changes
Other Study ID Numbers: ASD-1213-12
First Submitted: January 18, 2011
First Posted: January 19, 2011
Last Update Posted: January 27, 2011
Last Verified: June 2009

Keywords provided by Isfahan University of Medical Sciences:
Flap
leg defect
reconstruction
tissue