Breast Reconstruction, Deep Inferior Epigastric Perforator, Microvascular Free Flap Transfer
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCaffeinated Coffee
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.
DIETARY_SUPPLEMENTDecaffeinatedCoffee
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Patient and observer will be blinded to which group they were assigned.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* regular caffeine consumers undergoing unilateral or bilateral microsurgical breast reconstruction with DIEP flap(s) at the University of Michigan Health System
Exclusion criteria
* smokers * hepatic or renal disease (comorbidities that affect caffeine metabolism) * male
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of feasibility | approximately 6 months after recruitment starts | The total number of patients recruited per month, the rate of successful enrollment, and the rate of successful study completion will be evaluated. |
| Absolute value of tissue oxygenation saturation (StO2) | up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption) | St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations. |
| Absolute value of tissue oxygenation saturation (StO2) rate of change | up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption) | St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations. |
| Absolute value of tissue oxygenation saturation (StO2) amount of change | up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption) | St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of minor flap complications in the caffeine and non-caffeine groups | up to 30 days post-operatively | The complications will include delayed wound healing, wound dehiscence, hematoma, seroma formation, and infections requiring antibiotics. |
| Incidence of major flap complications in the caffeine and non-caffeine groups | up to 30 days post-operatively | 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). |
Countries
United States
Outcome results
None listed