Mastectomy Flap Temperature Study

Study Overview
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Brief Summary
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The purpose of this research study is to measure tissue temperatures and generate a prospective database of participants undergoing mastectomy with or without breast reconstruction at Wake Forest Baptist Hospital (WFBH) in order to enable and facilitate the evaluation of important and novel research questions - and quality improvement (QI) ideas/objectives - that may improve the care of breast surgery patients.

Detailed Description
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Primary Objective(s) Quantify the proportion of eligible women approached who consent to intraoperative (pre and post mastectomy) measurement of mastectomy flap temperatures in each of 4 quadrants of each relevant breast (i.e., unilateral or bilateral procedure). Quantify the proportion of patients upon whom the surgical team is able to obtain intraoperative flap measurements from each of 4 quadrants on each relevant breast pre- and post-mastectomy and pre-implant. Secondary Objective: To measure mastectomy flap temperatures in 4 quadrants pre-mastectomy, following mastectomy, and pre-implant, and compare average flap temperature to average core body temperature.

Official Title
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Mastectomy Flap Temperature and Clinical Implications

Conditions
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Breast Cancer, Mastectomy

Intervention / Treatment
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* Other: Myocardial Probe Temperature Screen
* Other: Data Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for unilateral or bilateral mastectomy with implant based breast reconstruction within the Wake Forest Baptist Health System. Aged 18 or older. Ability to understand an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: Those who are male.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative Data Collection Arm<br>Participants scheduled for mastectomy with or without breast reconstruction during the course of their breast surgery treatment will have breast skin temperatures taken using a myocardial probe in different anatomical breast areas at multiple time points during the surgery. | Other: Myocardial Probe Temperature Screen<br>* The myocardial probe is a needle that measures temperatures. The skin site for introducing the myocardial probe will be small enough that participants will not notice that temperatures have been collected. If participants have multiple operations, temperatures may be collected at each operation.<br>Other: Data Collection<br>* Study team members will collect medical history and other information to potentially understand the safety and success of breast surgery better to allow investigators to identify variables, or changes to help understand investigators roles in potential complications in breast surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery | This will be computed by the dividing the total number of eligible women screened by the number of women who consent by using a 95% confidence interval. | 90 days post surgery | 
| Number of Women Having All Relevant Flap Temperatures Measured | This will either be 12 or 24 total expected flap temperatures: 4 quadrants, at three time points- pre and post-mastectomy and pre-implant placement; one or both breasts), and we will compute a 95% confidence interval. | 90 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mastectomy Flap Temperatures and Core Body Temperatures | Mastectomy flap temperatures will be measured using a 22 gauge myocardial temperature sensor (Smiths Medical). Temperatures will be recorded in degrees Celsius. Core body temperature will also be collected to observe a difference between average mean flap temperature and average core body temperature. | 90 days post surgery |