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

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Other: No Intervention; Device: SurgiMend® PRS

• Registration Number: NCT01959867
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-27
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Status Verified: 2017-01
• Study Start: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Intervention	No Intervention	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 (ADM)	SurgiMend® PRS	Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).

Primary Outcome Measures

Name	Time	Method
Breast Q	12 months Post-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.
Capsular Contracture Rate	12 months Post-Exchange	Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange

Secondary Outcome Measures

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