Mastectomy Flap Temperature Study

Breast Cancer Clinical Trial

Official title:

Mastectomy Flap Temperature and Clinical Implications

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05395936
• Other study ID #: IRB00075787
• Secondary ID: WFBCCC 74222P30C
• Status: Terminated
• Phase: N/A
• Start date: September 29, 2022
• Est. completion date: March 17, 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 17, 2024
• Est. primary completion date: March 17, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Breast Cancer
• Mastectomy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 by using a 95% confidence interval.	90 days post surgery
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.	90 days post surgery
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 average mean flap temperature and average core body temperature.	90 days post surgery