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Completed

NCT Number: NCT06139588

Comparative Analysis of Two Animal-derived ADMs in Irradiated 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.

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Key information

Conditions

Breast Implant; Complications Breast Cancer Breast Diseases Breast Implant Infection Breast Implant Protrusion Breast Neoplasms Breast Seroma Foreign-Body Reaction Implant Capsular Contracture Inflammation Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

European Institute of Oncology

Milan, Lombardy, 20141, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acellular dermal matrix implant for breast reconstruction

Device

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

Primary outcomes

  1. ADM efficacy and risk profile comparison

    Time frame: 60 months

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

Secondary outcomes

  1. Best clinical setting for ADM use

    Time frame: 60 months

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

Other outcomes

  1. ADM comparison in each clinical setting group

    Time frame: 60 months

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

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study 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

Acronym: RTADM

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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