Post-Mastectomy Skin Flap Evaluation for Breast Cancer

BS
Overseen ByBenjamin Smith, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand skin and tissue changes after a mastectomy to predict risks in breast reconstruction. Researchers will collect tissue during routine surgery, review medical records, and ask participants to fill out questionnaires. The study is ideal for women who have had a mastectomy and currently have a temporary tissue expander, with plans for a permanent breast implant soon. As an unphased trial, participants contribute to valuable research that may improve future breast reconstruction outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve the safety and effectiveness of breast reconstruction surgeries. Unlike current approaches that primarily rely on visual assessment and surgeon experience, this study is investigating the mechanical properties of post-mastectomy skin flaps. By understanding these physical characteristics, doctors hope to better predict reconstruction risks, leading to more personalized and potentially successful treatment plans. This could ultimately reduce complications and enhance outcomes for patients undergoing reconstruction after breast cancer surgery.

Who Is on the Research Team?

BD

Benjamin D Smith, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I have had a mastectomy with a tissue expander placed.
I currently have a tissue expander in place.
I plan to have surgery to replace a tissue expander with a breast implant soon.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tissue Collection

Patients undergo tissue collection during standard of care surgery

At time of surgery

Data Collection

Medical records are reviewed and questionnaires are completed throughout the study

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Non-Interventional Study
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ObservationalExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Artidis

Industry Sponsor

Trials
5
Recruited
600+
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