Pre-pectoral Breast Reconstruction PART 2

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 be investigating the Two-stage, using Tissue Expander (TE) pre-pectoral reconstructions. The trial will comprise two arms: PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS 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 Pre-pectoral Implant Based Breast Reconstruction

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Two-stage with Acellular Dermal Matrix (CELLIS® Breast)
* Device: Two-stage 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), both 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: ADM two-stage reconstruction<br>Two-stage with Acellular Dermal Matrix (CELLIS® Breast). Tissue Expander A, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by ADM | Device: Two-stage with Acellular Dermal Matrix (CELLIS® Breast)<br>* After mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position. The tissue expander will be held in place by an ADM (CELLIS® Breast, MECCELLIS BIOTECH, 40 rue Chef de Baie, 17000, La Rochelle FRANCE) either completely wrapped around it or just covering its anterior surface. After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole. Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue.<br>* Other names: Fat grafting;|
| Experimental: TCPM two-stage reconstruction<br>Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra). Tissue Expander B, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by TCPM | Device: Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)<br>* After mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position. The tissue expander will be held in place by a Titanium Coated Polypropylene Mesh (TiLOOOP® Bra, pfm medical, ag Wankelstraße 60 ,50996 Köln GERMANY) either completely wrapped around it or just covering its anterior surface. After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole. Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue.<br>* Other names: 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 will be evaluated considering the rate in percentage of cases affected by the following complications among total number: 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. Rates will be compared between the two groups | up to 6 months | 
| Rate in percentage of technique failure | The failure rate, as percentage, will be compared between the two arms: failure will be the prosthesis (implant or TE) loss rate (reintervention with prosthesis removal) among overall number of prostheses implanted. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective quality of life assessment with Baker scale for capsular contracture | Long-term outcomes, after two years from mastectomy and at least 3 months from TE/implant exchange, in quality of life will entail first of all an objective assessment: such evaluation will include the capsular contracture rate, with the assessment of the reintervention rate for amelioration or for a reconstructive strategy change. Among these objective evaluations, any possible short-term complications after second-stage procedure will be investigated. | at 2 years from mastectomy | 
| Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale for scoring | A third party objective evaluation will be 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, giving a score for each patient. Scores from the two arms will be compared. | at 2 years from mastectomy | 
| Subjective quality of life assessment with BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved) | After 2 years from mastectomy and at least 3 months from TE/implant exchange a subjective evaluation will be carried out with BREAST-Q score (scores from the two arms will be transformed in 100 scale, summed and compared as median) | at 2 years from mastectomy |