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

Not Applicable

Withdrawn

• Conditions: Breast Cancer

• 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• Status: WITHDRAWN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

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)