Pre-pectoral Breast Reconstruction PART 1

Study Overview
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Brief Summary
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The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. Ahead of that, the trial aims to test if there is a difference in the outcomes between a biological and a synthetic material when placed as a support under the mastectomy skin flaps, both in terms of immediate complications and of long-term results.

Detailed Description
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This phase III randomized clinical trial will compare direct-to-implant pre-pectoral breast reconstruction with different supportive materials: the trial will comprise two arms: A-PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS B-PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING

Official Title
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Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in DIRECT-TO-IMPLANT (DTI) Pre-pectoral Implant Based Breast Reconstruction

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: DTI with Acellular Dermal Matrix (CELLIS® Breast)
* Device: DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM Nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM) Prophylactic and therapeutic. Included patients baseline characteristics will be: Age 18-80 years old BMI between 18.5 and 35. Former smokers (up until 3 weeks before surgery) Hypertension at oral medications Diabetes Previous breast surgery Previous breast and chest wall radiation therapy will be allowed. Exclusion Criteria: T4 and metastatic breast cancers Obese patients (BMI over 35) Currently smoking patients (within 3 weeks before surgery) Refusal to sign the consent Severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct-To-Implant A<br>DTI with Acellular Dermal Matrix (CELLIS® Breast), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of an Acelluar Dermal Matrix (ADM) | Device: DTI with Acellular Dermal Matrix (CELLIS® Breast)<br>* After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using an ADM (CELLIS® Breast), either completely covering the implant or simply covering the anterior surface of it. The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.<br>* Other names: Pre-pectoral Direct-to-implant with ADM, fat grafting;|
| Experimental: Direct-To-Implant B<br>DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of a titanium coated polypropylene mesh | Device: DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)<br>* After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using a TCPM (TiLOOOP® Bra), either completely covering the implant or simply covering the anterior surface of it.The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.<br>* Other names: Pre-pectoral Direct-to-implant with TCPM, fat grafting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate in percentage of surgical complications | Surgical outcomes within the first six months from mastectomy and IBBR will be evaluated with the statistical difference in percentage rate of complicated and non complicated patients between the two groups. Complications will be the following: surgical site infection (any infection requiring an antibiotic therapy, either oral or intravenous), wound dehiscence, seroma (any fluid collection requiring aspiration for more than a month from mastectomy), nipple/skin necrosis (either partial or complete), hematoma, red breast syndrome, with their reintervention rate, all in percentages. | up to 6 months | 
| Rate in percentage of technique failure | The failure rate will be assessed considering the statistical difference in percentage rate of removed implants among total number and comparing them between the two arms: in other words the prostheses (implants) loss rate (reinterventions with prosthesis removal). | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective quality of life assessment with Baker scale for capsular contracture | Quality of life outcomes at 2 years from mastectomy and at least 3 months after completion of the reconstructive step included in the protocol (one fat grafting procedure) will entail first of all an objective evaluation: such evaluation will be performed with the the scoring of capsular contracture rate, including assessment of the reintervention rate for amelioration or for a reconstructive strategy change, comparing the two arms. | at 2 years from mastectomy | 
| Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale scoring | In addition another objective analysis will include a third party objective evaluation, carried out by a group of a surgeon, a nurse and a lay person from a different center from that one where every single case was performed. This third party evaluation will assess the cosmetic outcome based on medical photographic files. Scores from this ranking will be compared between the two groups. | at 2 years from mastectomy | 
| Subjective quality of life assessment using the BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved). | Quality of life outcomes at 2 years from mastectomy and at least 3 months after completion of the reconstructive step included in the protocol (one fat grafting procedure) will entail also a subjective evaluation: such evaluation will be carried out using the BREAST-Q questionnaire. Scores will be transformed in a 100 scale and compared as median between the two groups. | at 2 years from mastectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-pectoral breast reconstruction, subcutaneous breast reconstruction