MedTrace Logo

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

NCT04249934 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-03-11

No results posted yet for this study

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.

Conditions

  • Breast Reconstruction
  • Deep Inferior Epigastric Perforator
  • Microvascular Free Flap Transfer

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Adeyiza Momoh, MD · University of Michigan

  • Theodore A Kung, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2020-03-16
Completion
2020-03-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04249934 on ClinicalTrials.gov