A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction

Study Overview
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Brief Summary
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The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.

Official Title
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A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)
* Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females aged 21-60 years Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage Planning to undergo nipple-sparing or skin-sparing mastectomy Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion Intraoperative confirmation of prepectoral plane viability by operating physician Exclusion Criteria: History of radiotherapy to the operative breast Current smoker Non-English speaking patients Planning to undergo direct-to-implant reconstruction Prior sternotomy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Prepectoral Breast Reconstruction with ADM<br> | Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)<br>* Prepectoral Breast Reconstruction with (ADM)<br>|
| Experimental: Prepectoral Breast Reconstruction without ADM<br> | Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)<br>* Prepectoral Breast Reconstruction without ADM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who experience major complications | Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis): Infection defined as: Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics Purulent drainage from the surgical site or incision Explantation defined as the need for removal of a TE for any cause Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate rates of minor complications (specifically seroma) | Minor complication for (Tissue Expanders) TEs are defined as: o Seroma: Clinically significant noninfected fluid collection requiring either needle aspiration or drain replacement | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acellular Dermal Matrix, Breast Reconstruction, Mastectomy, 22-071