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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post surgery

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,239 Previous Clinical Trials

1,004,163 Total Patients Enrolled

32 Trials studying Breast Cancer

5,020 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,133 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,340 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are accepted for this study's enrollment?

"Affirmative. The information available on clinicaltrials.gov confirms that this medical trial, initially posted in September 29th 2022, is still actively searching for new patients to include in the study. A total of 30 participants will be recruited from one site nationwide."

Answered by AI

Does this clinical trial accept new participants at the present time?

"Clinicaltrials.gov reports that this clinical trial is presently enlisting patients; the initial post was on September 29th 2022 and it has been recently modified as of November 2nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mastectomy Flap Temperature Study

2022. "Mastectomy Flap Temperature Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05395936.