SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy

Study Overview
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Brief Summary
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This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.

Official Title
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Clinical Study Comparing Two-Stage Breast Reconstruction Following Mastectomy With and Without the Use of SurgiMend® PRS Fetal Bovine Collagen Matrix in Patients With Pre-Mastectomy Radiation Therapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: SurgiMend® PRS
* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years of age Patient is female Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy & reconstruction) Patient utilized a textured expander only Patient utilized a smooth gel permanent implant only Patient has agreed and is able to comply with the study follow-up requirements Patient or guardian has provided consent for participation Exclusion Criteria: Patient is undergoing single-stage breast reconstruction Patient is undergoing a delayed reconstruction Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant. Patient is undergoing planned reconstruction using autologous tissue Patient has a known hypersensitivity to collagen or bovine derived materials Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SurgiMend® PRS (ADM)<br>Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion). | Device: SurgiMend® PRS<br>* Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).<br>* Other names: ADM, acellular dermal matrix;|
| Other: No Intervention<br>Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion). | Other: No Intervention<br>* Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capsular Contracture Rate | Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange | 12 months Post-Exchange | 
| Breast Q | No decrease in overall patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, all questions a-p. Increase in patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, questions related to capsular contracture. | 12 months Post-Exchange | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No. Capsule Procedures | Number of capsule procedures performed | 12 months Post-Exchange | 
| Cosmetic Assessment | Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs) | 12 months Post-Exchange | 
| Time to Completion | Time to Completion (expand-to-implant exchange) | 12 months Post-Exchange | 
| Total number of OR procedures | Procedural Attributes: Total number of OR procedures | 12 month follow-up visit | 
| Total number of visits | Procedural Attributes: Total number of (in office and OR procedures) | 12 month follow up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADM, mastectomy, breast reconstruction, bovine, breast cancer, breast implants, breast expanders, radiation therapy