Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Submuscolar reconstruction; Procedure: Prepectoral reconstruction

• Registration Number: NCT05125991
• Lead Sponsor: European Institute of Oncology

Brief Summary

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.

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 Timeline

• Study Start: 2019-09-03
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-11-18
• Status Verified: 2023-06
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Submuscular reconstruction	Submuscolar reconstruction	Submuscolar breast reconstruction
Prepectoral reconstruction	Prepectoral reconstruction	Prepectoral breast reconstruction with Braxon dermal matrix

Primary Outcome Measures

Name	Time	Method
Satisfaction assessed by the BREAST-Q	1 year	The BREAST-Q survey is used to detect differences in patient satisfaction among the groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy