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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
A single 8 ounce cup of regular starbucks coffee will be given to the participant in the am post operative day two. Participants will have 15 minutes to consume the coffee. Additionally, medical record data will be collected up to 30 days after surgery.
A single 8 ounce cup of decaffeinated starbucks coffee will be given to the participant in the am post operative day two. Participants will have 15 minutes to consume the coffee. Additionally, medical record data will be collected up to 30 days after surgery.
University of Michigan
Ann Arbor, Michigan, United States
Analysis of feasibility
The total number of patients recruited per month, the rate of successful enrollment, and the rate of successful study completion will be evaluated.
Time frame: approximately 6 months after recruitment starts
Absolute value of tissue oxygenation saturation (StO2)
St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations.
Time frame: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
Absolute value of tissue oxygenation saturation (StO2) rate of change
St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations.
Time frame: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
Absolute value of tissue oxygenation saturation (StO2) amount of change
St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations.
Time frame: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
Incidence of minor flap complications in the caffeine and non-caffeine groups
The complications will include delayed wound healing, wound dehiscence, hematoma, seroma formation, and infections requiring antibiotics.
Time frame: up to 30 days post-operatively
Incidence of major flap complications in the caffeine and non-caffeine groups
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These complications will include any event that results in an unplanned trip to the operating room (e.g. arterial or venous thrombosis), and flap loss (e.g. flap failure, flap death).
Time frame: up to 30 days post-operatively