Mastectomy Flap Temperature Study

Not Applicable

Terminated

Interventions: Other: Myocardial Probe Temperature Screen
Other: Data Collection

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Intraoperative Data Collection Arm	Data Collection	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.
Intraoperative Data Collection Arm	Myocardial Probe Temperature Screen	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.

Primary Outcome Measures

Name	Time	Method
Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery	90 days post surgery	This will be computed by the dividing the total number of eligible women screened by the number of women who consent.
Number of Women Having All Relevant Flap Temperatures Measured	90 days post surgery	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.

Secondary Outcome Measures

Name	Time	Method
Change in Mastectomy Flap Temperatures and Core Body Temperatures	At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery)	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 pre and post-mastectomy average mean flap temperature, average core body temperature and pre-implant average core body temperature and flap temperature readings.