The Effects of Indocyanine Green Angiography (IGA) on Deep Inferior Epigastric Artery Perforator (DIEP) Flap Design and Post-Operative Fat Necrosis
SPY
Observational Study to Compare Research-only Breast Ultrasound to Standard of Care Physical Exam for Identifying Tissue Necrosis in Post-mastectomy Patients Undergoing Planned Breast Reconstruction.
1 other identifier
observational
100
1 country
1
Brief Summary
The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMarch 24, 2016
March 1, 2016
3 years
May 19, 2014
March 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of post-operative fat necrosis
Prospectively evaluate the effect of intra-operative IGA on both DIEP flap design, and rate of post-operative DIEP fat necrosis as compared by physical exam and breast ultrasound.
3-6 months post-operatively
Study Arms (1)
Ultrasound
Breast ultrasound in female patients who are post-mastectomy pursuing autologous tissue breast reconstruction surgery.
Eligibility Criteria
Females pursuing breast reconstruction after having undergone mastectomy. In the overwhelming majority of cases, this procedure is indicated for breast cancer treatment. Eligible patients will have their breast reconstruction done at the University of Washington Medical Center.
You may qualify if:
- Female patients at the University of Washington
- Aged twenty-five to sixty-five years
- Pursuing immediate or delayed, DIEP-based, autologous, microsurgical breast reconstruction at the University of Washington Medical Center
You may not qualify if:
- Patients unsuitable for autologous, microsurgical breast reconstruction utilizing the DIEP flap - i.e. patients who have undergone prior extensive abdominal surgeries, have inadequate abdominal tissue bulk, who cannot comply with standardized post-operative restrictions / assessments or patients afflicted with a medical condition(s) precluding prolonged general anesthesia and surgery.
- Patients who have a known allergy to contrast media will also be excluded from this study.
- Patients unable to read and write in English will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington Medical Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Project Manager
Study Record Dates
First Submitted
May 19, 2014
First Posted
May 22, 2014
Study Start
January 1, 2014
Primary Completion
January 1, 2017
Study Completion
September 1, 2020
Last Updated
March 24, 2016
Record last verified: 2016-03