Using AlloMend for breast reconstruction after mastectomy
Official title: A Retrospective 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 6-Months Post-Operatively.
Run by AlloSource · NCT06512259 · Data updated 2026-11-12
This study tests if using AlloMend® in breast reconstruction after mastectomy helps women have better results with their implants.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | AlloSource Industry-sponsored |
| Locations | 1 site (Joliet, Illinois) |
| Status | Recruiting |
| Started | October 19, 2023 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT06512259 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older who have undergone single or double mastectomy and received AlloMend® Acellular Dermal Matrix allograft for pre-pectoral breast reconstruction.
✕Probably not a fit
Patients who did not use AlloMend® Acellular Dermal Matrix allograft during their reconstruction will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the effectiveness of AlloMend® Acellular Dermal Matrix allograft in women who have undergone pre-pectoral breast reconstruction following single or double mastectomy. The study is retrospective and focuses on patients who received the AlloMend® allograft to stabilize implant position and minimize loss during reconstruction. Participants will have follow-up evaluations at specified intervals to assess outcomes related to the surgical intervention.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and patient satisfaction in breast reconstruction after mastectomy.
How similar studies have gone: While there may be studies on similar allografts, the specific use of AlloMend® in this context is relatively novel and not extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients must meet the following inclusion criteria to participate in this study: * Diagnosed by a physician and required a single or double mastectomy followed by Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft; * Surgical intervention using AlloMend® Acellular Dermal Matrix allograft was used; * Has completed or will complete the anticipated clinically indicated follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months post-surgical intervention. 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 it's running
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Alan H. Chen Surgical Associates, PC
Joliet, Illinois, United States Recruiting
Study contacts
- Study coordinator: Elizabeth Esterl, DNP, MS, RN
- Email: eesterl@allosource.org
- Phone: 7207326231
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.