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

Breast Reconstruction Clinical Trial

Official title:

The Effects of Caffeine on DIEP Flap Perfusion: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04249934
• Other study ID #: HUM00142366
• Status: Withdrawn
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: March 16, 2020

Study information

• Verified date: March 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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	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
Secondary	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