Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2022-09-29
2024-03-17
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 or older.
* Ability to understand an IRB-approved informed consent document (either directly or via a legally authorized representative).
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Adam Katz, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Health Sciences
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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WFBCCC 74222
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00075787
Identifier Type: -
Identifier Source: org_study_id