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

NCT06139588 | Completed

• 1 other identifier: UID4321
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

implant-based; breast reconstruction; adm; radiation therapy; irradiated breast

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Best clinical setting for ADM use

  60 months

Other Outcomes (1)

• ADM comparison in each clinical setting group

  60 months

Study Arms (8)

POST QUART NATIVE

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

Device: acellular dermal matrix implant for breast reconstruction

POST QUART VERITAS

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

Device: acellular dermal matrix implant for breast reconstruction

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

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

IMPLANT EXCHANGE NATIVE

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

Device: acellular dermal matrix implant for breast reconstruction

IMPLANT EXCHANGE VERITAS

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

Device: acellular dermal matrix implant for breast reconstruction

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

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

Interventions

acellular dermal matrix implant for breast reconstruction DEVICE

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

IMPANT EXCHANGE AFTER QUART NATIVE; IMPLANT EXCHANGE AFTER QUART VERITAS; IMPLANT EXCHANGE NATIVE; IMPLANT EXCHANGE VERITAS; POST EXPANDER NATIVE; POST EXPANDER VERITAS; POST QUART NATIVE; POST QUART VERITAS

Eligibility Criteria

• Gender Eligibility Details: female patients undergoing breast reconstruction after mastectomy
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• at least 6 months follow up
• breast reconstruction with implant + acellular dermal matrix after mastectomy and radiotherapy

You may not qualify if:

• mastectomy flap \<1 cm
• autoimmune disease
• prolonged use of corticosteroids

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Lombardy, 20141, Italy

Location

MeSH Terms

Conditions

Implant Capsular Contracture; Breast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Foreign-Body Reaction; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prosthesis Failure; Postoperative Complications; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Andrea Vittorio Emanuele Lisa, MD

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: June 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: October 13, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-10

Locations

IT (1)