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Flap Temperature Monitoring for Mastectomy Patients

N/A
Waitlist Available
Led By Adam Katz, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post surgery
Awards & highlights

Study Summary

This trialaims to measure tissue temperatures and create a database of patients having mastectomies or breast reconstructions at WFBH to inform better care.

Who is the study for?
This study is for women aged 18 or older who understand the consent form and are scheduled for a mastectomy with implant-based breast reconstruction at Wake Forest Baptist Health System. Men cannot participate.Check my eligibility
What is being tested?
The trial involves measuring tissue temperatures during mastectomy procedures using a myocardial probe, along with collecting data to potentially improve future breast surgery care.See study design
What are the potential side effects?
Since this trial focuses on temperature measurement and data collection rather than medication or invasive treatments, it does not have direct side effects like drug trials.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery
Number of Women Having All Relevant Flap Temperatures Measured
Secondary outcome measures
Change in Mastectomy Flap Temperatures and Core Body Temperatures

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intraoperative Data Collection ArmExperimental Treatment2 Interventions
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.

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,250 Previous Clinical Trials
1,007,158 Total Patients Enrolled
34 Trials studying Breast Cancer
5,067 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,344 Total Patients Enrolled
941 Trials studying Breast Cancer
1,543,946 Patients Enrolled for Breast Cancer
Adam Katz, MDPrincipal InvestigatorWake Forest Baptist Health Sciences
3 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

Mastectomy Clinical Trial Eligibility Overview. Trial Name: NCT05395936 — N/A
Breast Cancer Research Study Groups: Intraoperative Data Collection Arm
Breast Cancer Clinical Trial 2023: Mastectomy Highlights & Side Effects. Trial Name: NCT05395936 — N/A
Mastectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05395936 — N/A
~7 spots leftby Jun 2025
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