Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Prepectoral reconstruction
* Procedure: Submuscolar reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Not smokers No vascular comorbidities (diabetic, vasculitis, coagulation disorders) BMI<30 CUP B-C (or mastectomy estimated weight less than 550gm) Good subcutaneous layer (>1cm on pinch test measured in upper/medial quadrant) No previous breast surgery No previous breast irradiation Breast Ptosis 1-2 according to Renault's classification DCIS tumors T1 T2 pN0 breast tumor with known favourable biologic features Exclusion Criteria: Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality) Positive sentinel node biopsy requiring complete axillary dissection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prepectoral reconstruction<br>Prepectoral breast reconstruction with Braxon dermal matrix | Procedure: Prepectoral reconstruction<br>* Prepectoral breast reconstruction<br>|
| Active Comparator: Submuscular reconstruction<br>Submuscolar breast reconstruction | Procedure: Submuscolar reconstruction<br>* Submuscolar breast reconstruction<br>|

What is the study measuring?
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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 |