Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).

Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).

SurgiMend® PRS

No Intervention

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.

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

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

Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange

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.

Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs)

Time to Completion (expand-to-implant exchange)

Procedural Attributes: Total number of OR procedures

Procedural Attributes: Total number of ("in office" and OR procedures)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy	NCT01959867	Breast Cancer	SurgiMend® PRS No Intervention	18 Years -	Integra LifeSciences Corporation
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy	NCT01959867	Breast Cancer	SurgiMend® PRS No Intervention	18 Years -	Integra LifeSciences Corporation
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy	NCT01959867	Breast Cancer	SurgiMend® PRS No Intervention	18 Years -	Integra LifeSciences Corporation

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