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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-20

Study Completion Date

2027-08-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No