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Fasciocutaneous Flaps for Leg Defects

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ClinicalTrials.gov Identifier: NCT01278836
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : January 27, 2011
Sponsor:
Information provided by:
Isfahan University of Medical Sciences

Brief Summary:
The purpose of this study is to determine the effects of fasciocutaneous flaps for leg defects.

Condition or disease Intervention/treatment Phase
Limb Defects Procedure: fasciocutaneous flap Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Fasciocutaneous Flaps for Treatment of Leg Defects
Study Start Date : June 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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.



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

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


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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

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

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 Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: June 2009

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