Clinical trial · Observational
Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks, the EMPOWER Study
EMPOwER: Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks
NCT06584396CI-TRIAL-00105281active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
This study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy.
Conditions
Conditions (1)
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (1)
- measure
- Nanomechanical properties of the skin and adjacent soft tissue
- timeFrame
- At time of surgery
- description
- The nanomechanical properties will be presented as a histogram that describes the characteristics of the sample. For each skin sample, summary statistics including mean (median), standard deviation, skewness, and range, mode, etc. will be used to describe the nanomechanical properties. Wilcoxon rank sum test or Fisher's exact test will be used to study the association between the summarized nanomechanical properties and clinical factors or outcomes. Pearson correlation coefficients will be used to assess the strength of association between any two continuous variables. Logistic regression will be conducted to examine the effect of nanomechanical properties on the risk of implant loss or any complication after adjusting other clinical factors.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \* Age 18 and older * Female sex * Patient with history of mastectomy with tissue expander placement * Tissue expander in place at time of study enrollment * Patient plans to undergo surgery to exchange tissue expander for permanent breast implant within the next 3 months of signing the informed consent * Ability to understand and provide written informed consent in accordance with institutional policies
References
Publications (0)
Data not yet available
No reference posted for this study.