Breast ReconstructionNCT04249934
The Effects of Caffeine on Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
A study testing Caffeinated Coffee and DecaffeinatedCoffee in people with Breast Reconstruction and Deep Inferior Epigastric Perforator, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Deep Inferior Epigastric Perforator, Microvascular Free Flap Transfer
- What is being tested?
- Caffeinated Coffee and DecaffeinatedCoffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2020to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- regular caffeine consumers undergoing unilateral or bilateral microsurgical breast reconstruction with DIEP flap(s) at the University of Michigan Health System
Who cannot join
- smokers
- hepatic or renal disease (comorbidities that affect caffeine metabolism)
- male
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Caffeine on DIEP Flap Perfusion: A Pilot Study
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
- Breast Reconstruction, Deep Inferior Epigastric Perforator, Microvascular Free Flap Transfer
- Being tested
- Caffeinated Coffee, DecaffeinatedCoffee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeinated CoffeeDietary 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.
DecaffeinatedCoffeeDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Caffeinated Coffee | Experimental | Not described Receives: Dietary Supplement: Caffeinated Coffee |
| Decaffeinated Coffee | Active comparator | Not described Receives: Dietary Supplement: DecaffeinatedCoffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
Secondary outcomes (2)
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.
Measured: 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).
Measured: up to 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start15 Feb 2020
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Due to restrictions related to patient care secondary to covid pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeyiza Momoh, University of Michigan
- Investigators
- Adeyiza Momoh, MD, Principal investigator, University of MichiganTheodore A Kung, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249934
- Sponsor's protocol ID
- HUM00142366
- Status last verified
- Mar 2021
- First submitted
- 29 Jan 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Caffeine on DIEP Flap Perfusion: A Pilot Study
- ClinicalTrials.gov ID
- NCT04249934
- Acronym / sponsor ID
- HUM00142366
- Conditions
- Breast Reconstruction, Deep Inferior Epigastric Perforator, Microvascular Free Flap Transfer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to restrictions related to patient care secondary to covid pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeinated Coffee | Experimental | Dietary Supplement: Caffeinated Coffee |
| Decaffeinated Coffee | Active comparator | Dietary Supplement: DecaffeinatedCoffee |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- regular caffeine consumers undergoing unilateral or bilateral microsurgical breast reconstruction with DIEP flap(s) at the University of Michigan Health System
Key exclusion criteria (3 listed)
- smokers
- hepatic or renal disease (comorbidities that affect caffeine metabolism)
- male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeinated CoffeeA 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 | Caffeinated Coffee |
| DecaffeinatedCoffeeA 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. | Dietary supplement | Decaffeinated Coffee |
Primary outcome
Analysis of feasibility
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Incidence of minor flap complications in the caffeine and non-caffeine groups
Time frame: up to 30 days post-operatively
Incidence of major flap complications in the caffeine and non-caffeine groups
Time frame: up to 30 days post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeyiza Momoh, MD principal investigator
University of Michigan
Theodore A Kung, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeinated Coffee and DecaffeinatedCoffee in people with Breast Reconstruction and Deep Inferior Epigastric Perforator, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of feasibility (time frame: approximately 6 months after recruitment starts). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.