Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks, the EMPOWER Study

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06584396
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2023-09-20
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 110

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States