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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 74222 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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low accruals
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Primary Objective(s)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Data Collection Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myocardial Probe Temperature Screen | Other | 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. |
| 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. | 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 |
| 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 pre and post-mastectomy average mean flap temperature, average core body temperature and pre-implant average core body temperature and flap temperature readings. |
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Inclusion Criteria:
Exclusion Criteria: Those who are male.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Katz, MD | Wake Forest Baptist Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 22 eligible women were approached to participate, 19 agreed to participate in the study | Posted | Count of Participants | Participants | 90 days post surgery |
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Participants will be followed for 90 days after surgery for adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Katz | Atrium Health Wake Forest Baptist Comprehensive Cancer Center | 336-716-4171 | akatz@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2022 | Oct 21, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2023 | Apr 29, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Data Collection | Other | 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. |
|
| At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Temperature measurements were only obtained for 15 of the participants in the study. | Posted | Count of Participants | Participants | 90 days post surgery |
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| 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. | Posted | Mean | Standard Deviation | Degrees Celsius | At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery) |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Post-mastectomy average flap temperature readings |
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| Pre-implant average core body temperature readings |
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| Pre-implant average flap temperature readings |
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