Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

Evaluation of the Effectiveness of the Prepectoral Breast Reconstruction With Braxon Dermal Matrix: a Randomized Controlled Study

The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Prepectoral reconstruction; Procedure: Submuscolar reconstruction

Detailed Description

The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.

The study plans to collect robust data to support the prepectoral implant placement and complete coverage of implant with acellular dermal matrix in the clinical practice.

Consequently, the project plans to move toward evidence-based medicine in breast reconstruction, avoiding marketing influences and surgeon experience as the sole source of evidence.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Informed consent
2. Not smokers
3. No vascular comorbidities (diabetic, vasculitis, coagulation disorders)
4. BMI<30
5. CUP B-C (or mastectomy estimated weight less than 550gm)
6. Good subcutaneous layer (>1cm on pinch test measured in upper/medial quadrant)
7. No previous breast surgery
8. No previous breast irradiation
9. Breast Ptosis 1-2 according to Renault's classification
10. DCIS tumors
11. T1 T2 pN0 breast tumor with known favourable biologic features

Exclusion Criteria:

1. Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)
2. Positive sentinel node biopsy requiring complete axillary dissection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prepectoral reconstruction; Prepectoral breast reconstruction with Braxon dermal matrix	Procedure: Prepectoral reconstruction; Prepectoral breast reconstruction
Active Comparator: Submuscular reconstruction; Submuscolar breast reconstruction	Procedure: Submuscolar reconstruction; Submuscolar breast reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction assessed by the BREAST-Q	The BREAST-Q survey is used to detect differences in patient satisfaction among the groups	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate complications rate	Compare post operative complications	1 month
Short term complications rate	Compare short term post operative complications	6 months
Long term complications rate	Compare long term post operative complications	24 months
Percentage of capsular contracture	Compare overall aesthetic outcomes (percentage of capsular contracture) using standardized photographs assessed by independent blinded observers	1 year

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Francesca De Lorenzi, PhD, MD, European Institute of Oncology; Principal Investigator: Paolo Veronesi, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IEO 1002/

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No