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

NCT06584396 | Active Not Recruiting

• 2 other identifiers: 2023-0320NCI-2023-05588
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Nanomechanical properties of the skin and adjacent soft tissue

  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.

  At time of surgery

Study Arms (1)

Observational

Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with history of mastectomy with tissue expander placement recruited from MD Anderson.

You may qualify if:

• \* 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Artidis: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Benjamin D Smith, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 4, 2024
• Study Start: September 20, 2023
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)