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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Implant Infection; Breast Implant; Complications; Implant Capsular Contracture; Breast Implant Protrusion; Breast Seroma
• Intervention / Treatment: Device: acellular dermal matrix implant for breast reconstruction

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).

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20141
      • European Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study focuses on female patients undergoing implant based reconstruction after radiotherapy assisted by the use of an acellular dermal matrix.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
POST QUART NATIVE; Native adm used in the setting of mastectomy and implant reconstruction after QUART	Device: acellular dermal matrix implant for breast reconstruction; acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy
POST QUART VERITAS; Veritas adm used in the setting of mastectomy and implant reconstruction after QUART	Device: acellular dermal matrix implant for breast reconstruction; acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy
POST EXPANDER NATIVE; Native adm used in the setting of expander removal and implant positioning after mastectomy + RT	Device: acellular dermal matrix implant for breast reconstruction; acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy
POST EXPANDER VERITAS; Veritas adm used in the setting of expander removal and implant positioning after mastectomy + RT	Device: acellular dermal matrix implant for breast reconstruction; acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy
IMPLANT EXCHANGE NATIVE; Native adm used in the setting of implant exchange after mastectomy + RT	Device: acellular dermal matrix implant for breast reconstruction; acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy
IMPLANT EXCHANGE VERITAS; Veritas adm used in the setting of implant exchange after mastectomy + RT	Device: acellular dermal matrix implant for breast reconstruction; acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy
IMPANT EXCHANGE AFTER QUART NATIVE; Native adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction	Device: acellular dermal matrix implant for breast reconstruction; acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy
IMPLANT EXCHANGE AFTER QUART VERITAS; Veritas adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction	Device: acellular dermal matrix implant for breast reconstruction; acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADM efficacy and risk profile comparison	Does one dermal matrix perform better than the other in terms of efficacy and complication rates?	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best clinical setting for ADM use	Is there a subgroup of patient where the use of ADM proves more beneficial than others?	60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADM comparison in each clinical setting group	Is there a type of dermal matrix that performs better than the other in a specific subgroup of patients?	60 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Andrea Vittorio Emanuele Lisa, MD, Istituto Europeo di Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): October 13, 2023

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: radiation therapy; breast reconstruction; implant-based; adm; irradiated breast
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Postoperative Complications; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Foreign-Body Reaction; Prosthesis Failure; Contracture; Implant Capsular Contracture
• Other Study ID Numbers: UID4321

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No