NCT04249934

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

February 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

January 29, 2020

Last Update Submit

March 8, 2021

Conditions

Breast ReconstructionDeep Inferior Epigastric PerforatorMicrovascular Free Flap Transfer

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Incidence of minor flap complications in the caffeine and non-caffeine groups

    up to 30 days post-operatively

  • Incidence of major flap complications in the caffeine and non-caffeine groups

    up to 30 days post-operatively

Study Arms (2)

Caffeinated Coffee

EXPERIMENTAL
Dietary Supplement: Caffeinated Coffee

Decaffeinated Coffee

ACTIVE COMPARATOR
Dietary Supplement: DecaffeinatedCoffee

Interventions

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.

Caffeinated Coffee
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.

Decaffeinated Coffee

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly women scheduled to undergo unilateral or bilateral microsurgical breast reconstruction will be enrolled
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • regular caffeine consumers undergoing unilateral or bilateral microsurgical breast reconstruction with DIEP flap(s) at the University of Michigan Health System

You may not qualify if:

  • smokers
  • hepatic or renal disease (comorbidities that affect caffeine metabolism)
  • male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Adeyiza Momoh, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Theodore A Kung, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient and observer will be blinded to which group they were assigned.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

January 29, 2020

First Posted

January 31, 2020

Study Start

February 15, 2020

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)