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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SurgiMend® PRS
No Intervention
Sponsored by
Integra LifeSciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring mastectomy, breast reconstruction, bovine, ADM, breast cancer, breast implants, breast expanders, radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    SurgiMend® PRS (ADM)

    No Intervention

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 27, 2013
    Last Updated
    January 6, 2017
    Sponsor
    Integra LifeSciences Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01959867
    Brief Title
    SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Integra LifeSciences Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    mastectomy, breast reconstruction, bovine, ADM, breast cancer, breast implants, breast expanders, radiation therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SurgiMend® PRS (ADM)
    Arm Type
    Experimental
    Arm Description
    Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).
    Arm Title
    No Intervention
    Arm Type
    Other
    Arm Description
    Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).
    Intervention Type
    Device
    Intervention Name(s)
    SurgiMend® PRS
    Other Intervention Name(s)
    ADM, acellular dermal matrix
    Intervention Description
    Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).
    Intervention Type
    Other
    Intervention Name(s)
    No Intervention
    Intervention Description
    Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).
    Primary Outcome Measure Information:
    Title
    Capsular Contracture Rate
    Description
    Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange
    Time Frame
    12 months Post-Exchange
    Title
    Breast Q
    Description
    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.
    Time Frame
    12 months Post-Exchange
    Secondary Outcome Measure Information:
    Title
    No. Capsule Procedures
    Description
    Number of capsule procedures performed
    Time Frame
    12 months Post-Exchange
    Title
    Cosmetic Assessment
    Description
    Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs)
    Time Frame
    12 months Post-Exchange
    Title
    Time to Completion
    Description
    Time to Completion (expand-to-implant exchange)
    Time Frame
    12 months Post-Exchange
    Title
    Total number of OR procedures
    Description
    Procedural Attributes: Total number of OR procedures
    Time Frame
    12 month follow-up visit
    Title
    Total number of visits
    Description
    Procedural Attributes: Total number of ("in office" and OR procedures)
    Time Frame
    12 month follow up visit

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Learn more about this trial

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

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