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Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap and Determining the Change in SIEA Diameter and Blood Flow

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ClinicalTrials.gov Identifier: NCT01247129
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : November 24, 2010
Sponsor:
Collaborator:
University Medical Centre Maribor
Information provided by:
University Medical Centre Ljubljana

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether delaying the superficial inferior epigastric artery (SIEA) flap results in widening of diameter and enhancing of blood flow of its donor artery.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Procedure: Delay procedure of SIEA flap. Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap: A Solution to the Problem of the Small Caliber of the Donor Artery
Study Start Date : September 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : September 2010

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SIEA,delay procedure,widening of diameter Procedure: Delay procedure of SIEA flap.
Ligating the deep inferior epigastric artery ipsilaterally to the planned raising of the SIEA flap 2 weeks prior to the reconstructive procedure.


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing surgery for lower extremities varicose veins

Exclusion Criteria:

  • patients who previously underwent operations of the lower abdomen (abdominoplasty and inguinal hernia repair)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01247129


Locations
Slovenia
University Medical Centre Maribor
Maribor, Slovenia, 2000
Sponsors and Collaborators
University Medical Centre Ljubljana
University Medical Centre Maribor
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Minja Gregorič, University Medical Centre Maribor
ClinicalTrials.gov Identifier: NCT01247129     History of Changes
Other Study ID Numbers: MG-2010
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: November 24, 2010
Last Verified: November 2010

Keywords provided by University Medical Centre Ljubljana:
Superficial inferior epigastric artery flap, delay phenomenon

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases