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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014