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

This study is not yet open for participant recruitment.
Verified October 2013 by TEI Biosciences Inc.
Sponsor:
Information provided by (Responsible Party):
TEI Biosciences Inc.
ClinicalTrials.gov Identifier:
NCT01959867
First received: September 27, 2013
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Device: SurgiMend® PRS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by TEI Biosciences Inc.:

Primary Outcome Measures:
  • Capsular Contracture Rate [ Time Frame: 12 months Post-Exchange ] [ Designated as safety issue: No ]
    Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange

  • Breast Q [ Time Frame: 12 months Post-Exchange ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 months Post-Exchange ] [ Designated as safety issue: Yes ]
    Number of capsule procedures performed

  • Cosmetic Assessment [ Time Frame: 12 months Post-Exchange ] [ Designated as safety issue: No ]
    Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs)

  • Time to Completion [ Time Frame: 12 months Post-Exchange ] [ Designated as safety issue: No ]
    Time to Completion (expand-to-implant exchange)

  • Total number of OR procedures [ Time Frame: 12 month follow-up visit ] [ Designated as safety issue: No ]
    Procedural Attributes: Total number of OR procedures

  • Total number of visits [ Time Frame: 12 month follow up visit ] [ Designated as safety issue: No ]
    Procedural Attributes: Total number of ("in office" and OR procedures)


Estimated Enrollment: 160
Study Start Date: January 2014
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SurgiMend® PRS (ADM)
Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).
Device: SurgiMend® PRS
Other Name: ADM, acellular dermal matrix
No Intervention: No ADM
Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01959867

Contacts
Contact: Andrea Werner 781-268-1616 ext 270 awerner@teibio.com

Sponsors and Collaborators
TEI Biosciences Inc.
  More Information

No publications provided

Responsible Party: TEI Biosciences Inc.
ClinicalTrials.gov Identifier: NCT01959867     History of Changes
Other Study ID Numbers: TEI-BR-001
Study First Received: September 27, 2013
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by TEI Biosciences Inc.:
mastectomy
breast reconstruction
bovine
ADM
breast cancer
breast implants
breast expanders
radiation therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014