Using AlloMend Acellular Dermal Matrix for Breast Reconstruction
A Study to Evaluate the Safety and Effectiveness of AlloMend® Acellular Dermal Matrix Used in Post Mastectomy Pre-Pectoral Breast Reconstruction and Followed for Up To 12-Months Post-Operatively
This study is testing if using AlloMend® Acellular Dermal Matrix can help improve breast reconstruction results for women who have had a mastectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | AlloSource Industry-sponsored |
| Locations | 1 site (Reno, Nevada) |
| Trial ID | NCT06853964 on ClinicalTrials.gov |
What this trial studies
This observational study examines the effectiveness of AlloMend® Acellular Dermal Matrix allograft in pre-pectoral breast reconstruction following single or double mastectomy. The study will collect data from approximately 200 breasts and up to 100 patients, focusing on clinical assessments, imaging, and patient-reported outcomes over a 12-month follow-up period. The AlloMend® allograft is designed to stabilize implant position and reduce the risk of implant loss during the reconstruction process. The study is conducted at a single center in the United States.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have undergone single or double mastectomy and utilized AlloMend® in their reconstruction.
Not a fit: Patients who did not use AlloMend® Acellular Dermal Matrix during their reconstruction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve outcomes for women undergoing breast reconstruction after mastectomy.
How similar studies have performed: Similar studies using acellular dermal matrices in breast reconstruction have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients must meet the following inclusion criteria to participate in this study: * Female ≥ 18 years old. * Patients have undergone a single or double mastectomy, followed by AlloMend® Acellular Dermal Matrix -assisted, pre-pectoral breast reconstruction. * Patients have undergone either one-stage (direct-to-implant) or two-stage (expander-to-implant), unilateral or bilateral pre-pectoral breast reconstruction using AlloMend®. Exclusion Criteria: Patients must not meet any of the following criteria to be considered for this clinical trial: * Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction * Did not have post-operative evaluations at the clinical site.
Where this trial is running
Reno, Nevada
- Janiga MDs Plastic Surgery and Cosmetic Center — Reno, Nevada, United States (Recruiting)
Study contacts
- Study coordinator: Elizabeth Esterl, DNP, MS, RN
- Email: eesterl@allosource.org
- Phone: 7207326231
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.