18 and older, female only, with Breast Cancer or Mastectomy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During SurgeryPrimary· 90 days post surgery
This will be computed by the dividing the total number of eligible women screened by the number of women who consent.
Group
Value
95% CI
Intraoperative Data Collection Arm
19
Number of Women Having All Relevant Flap Temperatures MeasuredPrimary· 90 days post surgery
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.
Group
Value
95% CI
Intraoperative Data Collection Arm
15
Change in Mastectomy Flap Temperatures and Core Body TemperaturesSecondary· At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery)
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 pre and post-mastectomy average mean flap temperature, average core body temperature and pre-implant average core body temperature and flap temperature readings.
Pre-mastectomy average core temperature readings
Group
Value
95% CI
Intraoperative Data Collection Arm
35.3
± 1.6
Pre-mastectomy average flap temperature readings
Group
Value
95% CI
Intraoperative Data Collection Arm
30.4
± 1.7
Post-mastectomy average core temperature readings
Group
Value
95% CI
Intraoperative Data Collection Arm
35.6
± 1.7
Post-mastectomy average flap temperature readings
Group
Value
95% CI
Intraoperative Data Collection Arm
29.9
± 2.0
Pre-implant average core body temperature readings
Group
Value
95% CI
Intraoperative Data Collection Arm
35.9
± 0.5
Pre-implant average flap temperature readings
Group
Value
95% CI
Intraoperative Data Collection Arm
29.0
± 1.9
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05395936.