The Effects of Caffeine on Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Caffeine on DIEP Flap Perfusion: A Pilot Study

Conditions
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Breast Reconstruction, Deep Inferior Epigastric Perforator, Microvascular Free Flap Transfer

Intervention / Treatment
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* Dietary Supplement: Caffeinated Coffee
* Dietary Supplement: DecaffeinatedCoffee


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caffeinated Coffee<br> | Dietary Supplement: Caffeinated Coffee<br>* 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.<br>|
| Active Comparator: Decaffeinated Coffee<br> | Dietary Supplement: DecaffeinatedCoffee<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 30 days post-operatively | 
| Incidence of major flap complications in the caffeine and non-caffeine groups | 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). | up to 30 days post-operatively |