Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

Study Overview
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Brief Summary
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Use of a HADM and implant in post-mastectomy breast reconstruction.

Detailed Description
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This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.

Official Title
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Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study

Conditions
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Mastectomy, Breast Reconstruction

Intervention / Treatment
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* Other: Flex HD Pliable Perforated HADM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction Mastectomy may be unilateral or bilateral, prophylactic or therapeutic Skin incision may be skin sparing, or nipple-areolar sparing Have signed written, informed consent Be at least 18 years of age Exclusion Criteria: Patients undergoing autologous breast reconstruction Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy) Patients undergoing reconstruction after previously failed attempts at reconstruction Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap) There will be no exclusions based on race or ethnicity BMI > 40 Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Flex HD Pliable Perforated HADM<br>Single Arm | Other: Flex HD Pliable Perforated HADM<br>* Human Acellular Dermal Matrix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types and incidence of complications | Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure | 6 months post reconstruction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic Outcomes | Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise | 6 months post reconstruction | 
| Patient-Reported Outcomes | Use of the Breast Q survey instrument | 6 months post reconstruction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dermal matrix