Investigation of FlexHD® Pliable in Breast Reconstruction
Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction
NA · Musculoskeletal Transplant Foundation · NCT06797258
This study is testing a new material called FlexHD® Pliable to see if it can improve the results of breast reconstruction surgery for women getting implants right after their mastectomy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 259 (estimated) |
| Ages | 22 Years and up |
| Sex | Female |
| Sponsor | Musculoskeletal Transplant Foundation (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Fort Worth, Texas) |
| Trial ID | NCT06797258 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, multi-center, single-arm study focusing on females who are scheduled for immediate implant-based breast reconstruction using a pre-pectoral technique. Participants will receive the FlexHD® Pliable intervention during their reconstruction procedure. The study aims to evaluate the safety and effectiveness of this approach in enhancing surgical outcomes. Participants will be monitored throughout the process to assess their recovery and overall satisfaction with the reconstruction.
Who should consider this trial
Good fit: Ideal candidates are females aged 22 and older who are undergoing unilateral or bilateral mastectomy with immediate implant-based, pre-pectoral breast reconstruction.
Not a fit: Patients who have undergone previous breast surgery at the implantation site or those with active tumors at the reconstruction site may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and patient satisfaction in breast reconstruction procedures.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in enhancing outcomes in breast reconstruction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Females at least 22 years of age * Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction * Willing to provide Informed Consent * Able to return for all required study visits * Must read and understand English language Exclusion Criteria: * Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure * Has a residual gross tumor at the intended reconstruction site * Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy * Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site * Completed chemotherapy within 3 weeks prior to surgery * Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications * Has a Body Mass Index (BMI) \>35 * Has used nicotine products within 1 month of screening * Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study
Where this trial is running
Fort Worth, Texas
- Jonathan Heistein, MD Plastic & Reconstructive Surgery — Fort Worth, Texas, United States (RECRUITING)
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.
Conditions: Implant Based Breast Reconstruction