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Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction

Comparative Study of the Efficacy and Risk Profile of Two Animal-derived Acellular Dermal Matrices in Patients Undergoing Mastectomy, Radiotherapy and Implant-based Reconstruction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06139588
Acronym
RTADM
Enrollment
146
Registered
2023-11-18
Start date
2017-06-01
Completion date
2023-10-13
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Implant; Complications, Breast Implant Infection, Breast Implant Protrusion, Breast Seroma, Implant Capsular Contracture

Keywords

implant-based, breast reconstruction, adm, radiation therapy, irradiated breast

Brief summary

The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss) The main questions the study aims to answer are: * is one of the two matrices better than the other? (better results with fewer complications) * is there a group of patients who benefit more than another from the use of this type of devices? * is there an adm which works better in one specific subgroup of patients? Participants have undergone mastectomy, radiotherapy and implant reconstruction with the aid of two different kinds of acellular dermal matrices. Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications.

Detailed description

Radiotherapy is highly effective in breast cancer treatment, yet it impairs satisfactory implant-based reconstruction, due to high rates of capsular contracture and implant loss. This said, a fervent investigtion exists upon solutions that can make implant-based reconstruction safer and aesthetically satisfying, including the use of acellular dermal matrices. We retrospectively want to analyze our ADM-assisted post-RT implant-based breast reconstructions comparing two different matrices (porcine and bovine), when autologous reconstruction was contraindicated, to assess eventual differences in efficacy and risk profile of the devices. We want to further stratify the population in 4 groups based on clinical presentation to assess if there was a group where ADMs proves to perform better (Group A - previous quadrantectomy, Group B - previous mastectomy and expander reconstruction, Group C - previous mastectomy and implant reconstruction, Group D - prior quadrantectomy followed by mastectomy and implant reconstruction).

Interventions

DEVICEacellular dermal matrix implant for breast reconstruction

acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy

Sponsors

European Institute of Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* at least 6 months follow up * breast reconstruction with implant + acellular dermal matrix after mastectomy and radiotherapy

Exclusion criteria

* mastectomy flap \<1 cm * autoimmune disease * prolonged use of corticosteroids

Design outcomes

Primary

MeasureTime frameDescription
ADM efficacy and risk profile comparison60 monthsDoes one dermal matrix perform better than the other in terms of efficacy and complication rates?

Secondary

MeasureTime frameDescription
Best clinical setting for ADM use60 monthsIs there a subgroup of patient where the use of ADM proves more beneficial than others?

Other

MeasureTime frameDescription
ADM comparison in each clinical setting group60 monthsIs there a type of dermal matrix that performs better than the other in a specific subgroup of patients?

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026