MedTrace Logo

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

NCT06139588 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 146

Last updated 2023-12-13

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

acellular dermal matrix implant for breast reconstruction

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

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Andrea Vittorio Emanuele Lisa, MD · Istituto Europeo di Oncologia

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2022-12-31
Completion
2023-10-13

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06139588 on ClinicalTrials.gov