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

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

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

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

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

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

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

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

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

acellular dermal matrix implant for breast reconstruction

Andrea Vittorio Emanuele Lisa, MD

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.

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).

female patients undergoing breast reconstruction after mastectomy

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

Is there a type of dermal matrix that performs better than the other in a specific subgroup of patients?

Does one dermal matrix perform better than the other in terms of efficacy and complication rates?

Is there a subgroup of patient where the use of ADM proves more beneficial than others?

European Institute of Oncology

Body Weight

Breast Diseases

Skin Diseases

Participants candidated to total mastectomy and radiotherapy will receive immediate or delayed breast reconstruction by the use of standard silicone-based breast implant (i.e. the breast implant commonly used in our institution)

Participants candidated to total mastectomy and radiotherapy will receive immediate or delayed breast reconstruction by the use of B-Lite® light weight breast implant

Definitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant

B-Lite® light weight breast implant

Definitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution

Standard silicone-based breast implant

Fabio Corsi, MD

Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.

Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer

Standard Silicone-based Breast Implant vs. B-Lite® Light Weight Breast Implant for Reconstructive Surgery After Total Mastectomy and Post-Mastectomy Radiotherapy for Breast Cancer: a Randomized Clinical Trial

Need of re-intervention for breast implant removal for any cause (such as breast implant exposure)

Occurrence of any complication at any time point, such as: capsular contracture, wound dehiscence, skin/soft tissues necrosis, inframammary fold break, implant exposure treated conservatively, hematoma, peri-prosthetic fluid collection, wound/implant infection

MRI evaluation for skin/soft tissues thinning, capsular contracture, implant break, chronic seroma

Objective evaluation of cosmetic outcome by jugular-nipple/areola complex (NAC) and NAC-inframammary fold distances to evaluate symmetry, objective evaluation of plastic surgeon with serial photographs

QoL evaluation included patient's satisfaction with breast reconstruction using the Body Image after Breast Cancer Questionnaire (BIBCQ)

QoL evaluation included patient's satisfaction with breast reconstruction, using the BREAST-Q score

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction	NCT06139588	Breast Implant;... Breast Implant ... Implant Capsula... Breast Seroma Breast Implant ... Breast Cancer	acellular derma...	-	European Institute of Oncology
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer	NCT03737500	Breast Implant;... Breast Implant ... Breast Cancer Radiotherapy Si...	B-Lite® light w... Standard silico...	18 Years - 75 Years	Istituti Clinici Scientifici Maugeri SpA

Spots Global Cancer Trial Database for breast implant protrusion