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

European Institute of Oncology

Status: Completed

Conditions: Breast Cancer; Breast Implant; Complications; Breast Implant Protrusion; Breast Seroma; Breast Implant Infection; Implant Capsular Contracture

Treatments: Device: acellular dermal matrix implant for breast reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT06139588

UID4321

Details and patient eligibility

About

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.

Full 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).

Enrollment: 146 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

146 participants in 8 patient groups

POST QUART NATIVE

Description:

Native adm used in the setting of mastectomy and implant reconstruction after QUART

Treatment:

Device: acellular dermal matrix implant for breast reconstruction

POST QUART VERITAS

Description:

Veritas adm used in the setting of mastectomy and implant reconstruction after QUART

Treatment:

Device: acellular dermal matrix implant for breast reconstruction

POST EXPANDER NATIVE

Description:

Native adm used in the setting of expander removal and implant positioning after mastectomy + RT

Treatment:

Device: acellular dermal matrix implant for breast reconstruction

POST EXPANDER VERITAS

Description:

Veritas adm used in the setting of expander removal and implant positioning after mastectomy + RT

Treatment:

Device: acellular dermal matrix implant for breast reconstruction

IMPLANT EXCHANGE NATIVE

Description:

Native adm used in the setting of implant exchange after mastectomy + RT

Treatment:

Device: acellular dermal matrix implant for breast reconstruction

IMPLANT EXCHANGE VERITAS

Description:

Veritas adm used in the setting of implant exchange after mastectomy + RT

Treatment:

Device: acellular dermal matrix implant for breast reconstruction

IMPANT EXCHANGE AFTER QUART NATIVE

Description:

Native adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction

Treatment:

Device: acellular dermal matrix implant for breast reconstruction

IMPLANT EXCHANGE AFTER QUART VERITAS

Description:

Veritas adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction

Treatment:

Device: acellular dermal matrix implant for breast reconstruction