Status:
TERMINATED
Mastectomy Flap Temperature Study
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Mastectomy
Eligibility:
FEMALE
18+ years
Phase:
NA
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 Bapt...
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 ...
Eligibility Criteria
Inclusion
- 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
- Those who are male.
Key Trial Info
Start Date :
September 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05395936
Start Date
September 29 2022
End Date
March 17 2024
Last Update
December 4 2024
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157