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

University of Michigan

Status: Withdrawn

Conditions: Breast Reconstruction; Microvascular Free Flap Transfer; Deep Inferior Epigastric Perforator

Treatments: Dietary Supplement: DecaffeinatedCoffee; Dietary Supplement: Caffeinated Coffee

Study type: Interventional

Funder types: Other

Identifiers

NCT04249934

HUM00142366

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Caffeinated Coffee

Experimental group

Treatment:

Dietary Supplement: Caffeinated Coffee

Decaffeinated Coffee

Active Comparator group

Treatment:

Dietary Supplement: DecaffeinatedCoffee