Breast Cancer, Mastectomy
Conditions
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.
Interventions
OTHERMyocardial Probe Temperature Screen
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.
OTHERData Collection
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.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intraoperative Data Collection Arm 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.
Myocardial Probe Temperature Screen: 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.
Data Collection: 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. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Intraoperative Data Collection Arm |
|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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.
Time frame: 90 days post surgery
Population: 22 eligible women were approached to participate, 19 agreed to participate in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intraoperative Data Collection Arm | Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery | 19 Participants |
Primary
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.
Time frame: 90 days post surgery
Population: Temperature measurements were only obtained for 15 of the participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intraoperative Data Collection Arm | Number of Women Having All Relevant Flap Temperatures Measured | 15 Participants |
Secondary
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 pre and post-mastectomy average mean flap temperature, average core body temperature and pre-implant average core body temperature and flap temperature readings.
Time frame: At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intraoperative Data Collection Arm | Change in Mastectomy Flap Temperatures and Core Body Temperatures | Pre-mastectomy average core temperature readings | 35.3 Degrees Celsius | Standard Deviation 1.6 |
| Intraoperative Data Collection Arm | Change in Mastectomy Flap Temperatures and Core Body Temperatures | Pre-mastectomy average flap temperature readings | 30.4 Degrees Celsius | Standard Deviation 1.7 |
| Intraoperative Data Collection Arm | Change in Mastectomy Flap Temperatures and Core Body Temperatures | Post-mastectomy average core temperature readings | 35.6 Degrees Celsius | Standard Deviation 1.7 |
| Intraoperative Data Collection Arm | Change in Mastectomy Flap Temperatures and Core Body Temperatures | Post-mastectomy average flap temperature readings | 29.9 Degrees Celsius | Standard Deviation 2 |
| Intraoperative Data Collection Arm | Change in Mastectomy Flap Temperatures and Core Body Temperatures | Pre-implant average core body temperature readings | 35.9 Degrees Celsius | Standard Deviation 0.5 |
| Intraoperative Data Collection Arm | Change in Mastectomy Flap Temperatures and Core Body Temperatures | Pre-implant average flap temperature readings | 29.0 Degrees Celsius | Standard Deviation 1.9 |
p-value: 0.0001t-test, 2 sided