Clinical trial · Interventional
Mastectomy Flap Temperature Study
Mastectomy Flap Temperature and Clinical Implications
NCT05395936CI-TRIAL-00083303terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accruals
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data Collection | Other | — | UNRESOLVED |
| Myocardial Probe Temperature Screen | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative Data Collection Arm
- description
- 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.
- interventionNames
- Other: Myocardial Probe Temperature Screen
- Other: Data Collection
Primary outcomes (2)
- measure
- Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery
- timeFrame
- 90 days post surgery
- description
- This will be computed by the dividing the total number of eligible women screened by the number of women who consent.
- measure
- Number of Women Having All Relevant Flap Temperatures Measured
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: Those who are male.
References
Publications (0)
Data not yet available
No reference posted for this study.