The Effects of Caffeine on Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
Withdrawn before enrolling · Not applicable
Conditions studied: Breast Reconstruction, Deep Inferior Epigastric Perforator, Microvascular Free Flap Transfer
In brief
Women that require breast reconstruction and meet eligibility will be enrolled in this study. The study is being completed to determine the effect of caffeine in deep inferior epigastric perforator (DIEP) flap perfusion using the Vioptix tissue oximeter monitor and to determine if caffeine in the acute postoperative period affects overall flap complication or loss (complete loss from anastomotic issue). The researchers hypothesize that a single 8 ounce cup of regular coffee will not affect free flap perfusion as indicated by the Vioptix, and that it will not affect overall free flap survival at thirty days.
Key facts
- Study ID
- NCT04249934
- Run by
- University of Michigan
- People needed
- 0
- Starts
- 2020-02-15
- Expected to finish
- 2020-03-16
- Last updated by the study team
- 2021-03-11
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- regular caffeine consumers undergoing unilateral or bilateral microsurgical breast reconstruction with DIEP flap(s) at the University of Michigan Health System
You may not qualify if…
- smokers
- hepatic or renal disease (comorbidities that affect caffeine metabolism)
- male
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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