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

Breast Cancer Clinical Trial

— RTADM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06139588
• Other study ID #: UID4321
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: October 13, 2023

Study information

• Verified date: October 2023
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: October 13, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Implant Infection
• Breast Implant Protrusion
• Breast Implant; Complications
• Contracture
• Implant Capsular Contracture

Intervention

Device:
• acellular dermal matrix implant for breast reconstruction
acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Best clinical setting for ADM use	Is there a subgroup of patient where the use of ADM proves more beneficial than others?	60 months