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

This study has been completed.
Sponsor:
Collaborator:
University Medical Centre Maribor
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01247129
First received: November 23, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention Phase
Breast Neoplasms
 Procedure: Delay procedure of SIEA flap.
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Enrollment: 26
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247129

Locations
Slovenia
University Medical Centre Maribor
Maribor, Slovenia, 2000
Sponsors and Collaborators
University Medical Centre Ljubljana
University Medical Centre Maribor
  More Information

No publications provided by University Medical Centre Ljubljana

Additional 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
Study First Received: November 23, 2010
Last Updated: November 23, 2010
Health Authority: Slovenia: Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 18, 2013