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

Not Applicable

Withdrawn

• Conditions: Deep Inferior Epigastric Perforator; Breast Reconstruction; Microvascular Free Flap Transfer
• Interventions: Dietary Supplement: Caffeinated Coffee; Dietary Supplement: DecaffeinatedCoffee

• Registration Number: NCT04249934
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Study Start: 2020-02-15
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caffeinated Coffee	Caffeinated Coffee	-
Decaffeinated Coffee	DecaffeinatedCoffee	-

Primary Outcome Measures

Name	Time	Method
Absolute value of tissue oxygenation saturation (StO2) amount of change	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.
Analysis of feasibility	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) rate of change	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)	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

Name	Time	Method
Incidence of minor flap complications in the caffeine and non-caffeine groups	up to 30 days post-operatively	The complications will include delayed wound healing, wound dehiscence, hematoma, seroma formation, and infections requiring antibiotics.
Incidence of major flap complications in the caffeine and non-caffeine groups	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).

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States