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

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ClinicalTrials.gov Identifier: NCT04249934
Recruitment Status : Withdrawn (Due to restrictions related to patient care secondary to covid pandemic.)
First Posted : January 31, 2020
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Adeyiza Momoh, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Breast Reconstruction Deep Inferior Epigastric Perforator Microvascular Free Flap Transfer Dietary Supplement: Caffeinated Coffee Dietary Supplement: DecaffeinatedCoffee Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Patient and observer will be blinded to which group they were assigned.
Primary Purpose: Other
Official Title: The Effects of Caffeine on DIEP Flap Perfusion: A Pilot Study
Actual Study Start Date : February 15, 2020
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: Caffeinated Coffee 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.

Active Comparator: Decaffeinated Coffee 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Incidence of minor flap complications in the caffeine and non-caffeine groups [ Time Frame: up to 30 days post-operatively ]
    The complications will include delayed wound healing, wound dehiscence, hematoma, seroma formation, and infections requiring antibiotics.

  2. Incidence of major flap complications in the caffeine and non-caffeine groups [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only women scheduled to undergo unilateral or bilateral microsurgical breast reconstruction will be enrolled
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249934


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Adeyiza Momoh, MD University of Michigan
Principal Investigator: Theodore A Kung, MD University of Michigan
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Responsible Party: Adeyiza Momoh, Associate Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT04249934    
Other Study ID Numbers: HUM00142366
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No