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Fasciocutaneous Flaps for Leg Defects

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01278836
First received: January 18, 2011
Last updated: January 26, 2011
Last verified: June 2009
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • venous congestion [ Time Frame: at three years after surgery ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with leg defects

Exclusion Criteria:

  • patients with underlying diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Isfahan university of medical sciences  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: January 18, 2011
Last Updated: January 26, 2011
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013