Evaluating skin properties after mastectomy for breast reconstruction
EMPOwER: Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks
This study is trying to learn more about the skin and soft tissue removed during breast reconstruction after a mastectomy to help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06584396 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on characterizing the nanomechanical properties of skin and surrounding soft tissue that are removed during implant reconstruction following a mastectomy. Patients who have undergone mastectomy with tissue expander placement will have tissue collected during their standard care surgery. Their medical records will be reviewed, and they will complete questionnaires throughout the study to gather comprehensive data on the reconstruction process and associated risks.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older who have a history of mastectomy with a tissue expander in place and plan to undergo surgery to exchange the expander for a permanent implant within three months.
Not a fit: Patients who do not have a history of mastectomy or those who are not planning to undergo implant reconstruction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help predict reconstruction risks and improve outcomes for patients undergoing breast reconstruction after mastectomy.
How similar studies have performed: While this approach is observational and focuses on mechanical properties, similar studies evaluating tissue characteristics in breast reconstruction have shown promise in improving surgical outcomes.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Benjamin D Smith, MD — M.D. Anderson Cancer Center
- Study coordinator: Benjamin Smith, MD
- Email: bsmith3@mdanderson.org
- Phone: (713) 563-2380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.