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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Breast Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06584396

NCI-2023-05588 (Registry Identifier)

2023-0320

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

140 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-Interventional Study