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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06584396

Enrollment

140

Registered

2024-09-04

Start date

2023-09-20

Completion date

2027-08-30

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

Brief summary

This study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy.

Detailed description

PRIMARY OBJECTIVE: I. Characterize the nanomechanical properties of the skin and adjacent soft tissue removed at the time of postmastectomy implant reconstruction. OUTLINE: This is an observational study. Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Nanomechanical properties of the skin and adjacent soft tissue	At time of surgery	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBenjamin D Smith, MD

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026