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Due to restrictions related to patient care secondary to covid pandemic.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeinated Coffee | Experimental |
| |
| Decaffeinated Coffee | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeinated Coffee | Dietary Supplement | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
only women scheduled to undergo unilateral or bilateral microsurgical breast reconstruction will be enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Adeyiza Momoh, MD | University of Michigan | Principal Investigator |
| Theodore A Kung, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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Patient and observer will be blinded to which group they were assigned.
|
| DecaffeinatedCoffee | Dietary Supplement | 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. |
|
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 |