Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps
The Potential Role of the Superficial Inferior Epigastric Vascular System in the Perfusion of Zone IV of Deep Inferior Epigastric Perforator (DIEP) Flaps
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Dec 2011
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2011
CompletedFirst Posted
Study publicly available on registry
November 4, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 14, 2012
May 1, 2012
1 year
October 30, 2011
May 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Deep Inferior Epigastric Perforator Flap Zone IV Tissue Perfusion
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.
Intra-Operatively
Study Arms (4)
SIE Vessels Both Clamped
ACTIVE COMPARATORSIE Vessels both Unclamped
ACTIVE COMPARATORSIE Artery Unclamped; Vein Clamped
ACTIVE COMPARATORSIE Artery Clamped, SIE Vein Unclamped
ACTIVE COMPARATORSuperficial Inferior Epigastric Artery Clamped; Vein Unclamped
Interventions
Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are clamped
Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are unclamped
Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is unclamped and the Vein is clamped
Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is clamped and the Vein is unclamped
Eligibility Criteria
You may qualify if:
- Female Patient
- Ages 18-70 years old
- Undergoing unilateral DIEP flap reconstruction post mastectomy.
You may not qualify if:
- Hyperthyroidism / history of autonomic thyroid adenoma (slightly increased risk of allergic reaction to the dye)
- ASA grade 3+
- Abdominal Scarring
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- Canniesburn Research Trustcollaborator
Study Sites (1)
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Gilmour, MBChB, MRCS (Ed)
Canniesburn Plastic Surgery Unit
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator - Clinical Laser Research Fellow
Study Record Dates
First Submitted
October 30, 2011
First Posted
November 4, 2011
Study Start
December 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
May 14, 2012
Record last verified: 2012-05