New tissue graft shows promise for breast reconstruction after mastectomy
NCT ID NCT06853964
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study evaluates the safety and effectiveness of AlloMend®, a human tissue graft, in women undergoing breast reconstruction after mastectomy. Researchers will review medical records of 100 patients to see how well the graft works and track any complications over 12 months. The goal is to understand if this approach leads to better surgical outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AlloMend® Acellular Dermal Matrix (a human tissue graft used to support breast reconstruction)
- What this could lead to
- If successful, this could confirm that AlloMend® is a safe and effective option for breast reconstruction after mastectomy, potentially improving surgical outcomes and reducing complications.
- What could go wrong
- This is a small, retrospective study (100 patients) that looks back at past records, so it cannot prove cause and effect. Results may not apply to all patients, and complications like infection or graft failure are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All patients who require a single or double mastectomy and have undergone Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft are eligible to participate. Patients who meet all the inclusion criteria but do not meet any of the exclusion criteria are eligible to enter the study.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Janiga MDs Plastic Surgery and Cosmetic Center
Reno, Nevada, 89521, United States