Mastectomy Flap Temperature Study

NCT05395936 | Terminated Results DMC

• 3 other identifiers: IRB00075787WFBCCC 74222P30CA012197
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer; Mastectomy

Outcome Measures

Primary Outcomes (2)

• 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.

  90 days post surgery

• 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 Outcomes (1)

• Change in Mastectomy Flap Temperatures and Core Body Temperatures

  At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery)

Study Arms (1)

Intraoperative Data Collection Arm

EXPERIMENTAL

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.

Other: Myocardial Probe Temperature Screen; Other: Data Collection

Interventions

Myocardial Probe Temperature Screen OTHER

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.

Intraoperative Data Collection Arm

Data Collection OTHER

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.

Intraoperative Data Collection Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Adam Katz
• Organization: Atrium Health Wake Forest Baptist Comprehensive Cancer Center

akatz@wakehealth.edu

336-716-4171

Study Officials

• Adam Katz, MD

  Wake Forest Baptist Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: September 29, 2022
• Primary Completion: March 17, 2024
• Study Completion: March 17, 2024
• Last Updated: December 4, 2024
• Results First Posted: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)