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

Breast Neoplasms Clinical Trial

Official title:

Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap: A Solution to the Problem of the Small Caliber of the Donor Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247129
• Other study ID #: MG-2010
• Status: Completed
• Phase: Phase 2
• First received: November 23, 2010
• Last updated: November 23, 2010
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Maribor	Maribor

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University Medical Centre Maribor

Country where clinical trial is conducted

Slovenia,