Trial Outcomes & Findings for Mastectomy Flap Temperature Study (NCT NCT05395936)
NCT ID: NCT05395936
Last Updated: 2024-12-04
Results Overview
This will be computed by the dividing the total number of eligible women screened by the number of women who consent.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
90 days post surgery
Results posted on
2024-12-04
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mastectomy Flap Temperature Study
Baseline characteristics by cohort
| Measure |
Intraoperative Data Collection Arm
n=19 Participants
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.
|
|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 days post surgeryPopulation: 22 eligible women were approached to participate, 19 agreed to participate in the study
This will be computed by the dividing the total number of eligible women screened by the number of women who consent.
Outcome measures
| Measure |
Intraoperative Data Collection Arm
n=22 Participants
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.
|
|---|---|
|
Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery
|
19 Participants
|
PRIMARY outcome
Timeframe: 90 days post surgeryPopulation: Temperature measurements were only obtained for 15 of the participants in the study.
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.
Outcome measures
| Measure |
Intraoperative Data Collection Arm
n=19 Participants
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.
|
|---|---|
|
Number of Women Having All Relevant Flap Temperatures Measured
|
15 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intraoperative Data Collection Arm
n=19 Participants
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.
|
|---|---|
|
Change in Mastectomy Flap Temperatures and Core Body Temperatures
Pre-mastectomy average core temperature readings
|
35.3 Degrees Celsius
Standard Deviation 1.6
|
|
Change in Mastectomy Flap Temperatures and Core Body Temperatures
Pre-mastectomy average flap temperature readings
|
30.4 Degrees Celsius
Standard Deviation 1.7
|
|
Change in Mastectomy Flap Temperatures and Core Body Temperatures
Post-mastectomy average core temperature readings
|
35.6 Degrees Celsius
Standard Deviation 1.7
|
|
Change in Mastectomy Flap Temperatures and Core Body Temperatures
Post-mastectomy average flap temperature readings
|
29.9 Degrees Celsius
Standard Deviation 2.0
|
|
Change in Mastectomy Flap Temperatures and Core Body Temperatures
Pre-implant average core body temperature readings
|
35.9 Degrees Celsius
Standard Deviation 0.5
|
|
Change in Mastectomy Flap Temperatures and Core Body Temperatures
Pre-implant average flap temperature readings
|
29.0 Degrees Celsius
Standard Deviation 1.9
|
Adverse Events
Intraoperative Data Collection Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Adam Katz
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-4171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place