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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Reconstruction; Deep Inferior Epigastric Perforator; Microvascular Free Flap Transfer
• Intervention / Treatment: Dietary supplement: Caffeinated Coffee; Dietary supplement: DecaffeinatedCoffee

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Adeyiza Momoh, MD, University of Michigan; Principal Investigator: Theodore A Kung, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2020
• Primary Completion (ACTUAL): March 16, 2020
• Study Completion (ACTUAL): March 16, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HUM00142366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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