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Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Canniesburn Research Trust
Information provided by (Responsible Party):
Adam Gilmour, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01464970
First received: October 30, 2011
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to determine in-vivo the effects the contralateral superficial inferior epigastric vascular system has on the perfusion of Zone IV of deep inferior epigastric perforator flaps.


Condition Intervention
Breast Cancer
 Procedure: Both Superficial Inferior Artery and Vein Clamped
Procedure: Superficial Inferior Epigastric Vessels both unclamped
Procedure: SIE Artery Unclamped, Vein Clamped
Procedure: SIE Artery clamped, Vein unclamped

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Potential Role of the Superficial Inferior Epigastric Vascular System in the Perfusion of Zone IV of Deep Inferior Epigastric Perforator (DIEP) Flaps

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Deep Inferior Epigastric Perforator Flap Zone IV Tissue Perfusion [ Time Frame: Intra-Operatively ] [ Designated as safety issue: No ]
    Tissue Perfusion to Zone IV will be assessed intra-operatively using Laser Doppler Imaging and angiography whilst various components of the Contralateral Superficial Inferior Epigastic Artery / Vein are clamped/unclamped.


Estimated Enrollment: 12
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SIE Vessels Both Clamped Procedure: Both Superficial Inferior Artery and Vein Clamped
Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are clamped
Active Comparator: SIE Vessels both Unclamped Procedure: Superficial Inferior Epigastric Vessels both unclamped
Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are unclamped
Active Comparator: SIE Artery Unclamped; Vein Clamped Procedure: SIE Artery Unclamped, Vein Clamped
Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is unclamped and the Vein is clamped
Active Comparator: SIE Artery Clamped, SIE Vein Unclamped
Superficial Inferior Epigastric Artery Clamped; Vein Unclamped
 Procedure: SIE Artery clamped, Vein unclamped
Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is clamped and the Vein is unclamped

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female Patient
  • Ages 18-70 years old
  • Undergoing unilateral DIEP flap reconstruction post mastectomy.

Exclusion Criteria:

  • Hyperthyroidism / history of autonomic thyroid adenoma (slightly increased risk of allergic reaction to the dye)
  • ASA grade 3+
  • Abdominal Scarring
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464970

Locations
United Kingdom
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Canniesburn Research Trust
Investigators
Principal Investigator: Adam Gilmour, MBChB, MRCS (Ed) Canniesburn Plastic Surgery Unit
  More Information

No publications provided

Responsible Party: Adam Gilmour, Principal Investigator - Clinical Laser Research Fellow, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01464970     History of Changes
Other Study ID Numbers: GN11CA415
Study First Received: October 30, 2011
Last Updated: May 11, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United Kingdom: National Institute for Health Research

Keywords provided by NHS Greater Glasgow and Clyde:
DIEP perfusion
Zone IV
Free Flap
Breast Cancer Reconstruction
Perfusion of Zone IV of DIEP flaps

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Diclofenac hydroxyethylpyrrolidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013