Trials / Withdrawn
WithdrawnNCT04249934
The Effects of Caffeine on Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
The Effects of Caffeine on DIEP Flap Perfusion: A Pilot Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Caffeinated 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_SUPPLEMENT | DecaffeinatedCoffee | 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. |
Timeline
- Start date
- 2020-02-15
- Primary completion
- 2020-03-16
- Completion
- 2020-03-16
- First posted
- 2020-01-31
- Last updated
- 2021-03-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04249934. Inclusion in this directory is not an endorsement.