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

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ClinicalTrials.gov Identifier: NCT01959867
Recruitment Status : Withdrawn
First Posted : October 10, 2013
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Breast Cancer Device: SurgiMend® PRS Other: No Intervention

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2017
Primary Completion Date : January 2017
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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
Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).
Other Name: ADM, acellular dermal matrix
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).
Other: 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).


Outcome Measures

Primary Outcome Measures :
  1. Capsular Contracture Rate [ Time Frame: 12 months Post-Exchange ]
    Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange

  2. Breast Q [ Time Frame: 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.



Secondary Outcome Measures :
  1. No. Capsule Procedures [ Time Frame: 12 months Post-Exchange ]
    Number of capsule procedures performed

  2. Cosmetic Assessment [ Time Frame: 12 months Post-Exchange ]
    Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs)

  3. Time to Completion [ Time Frame: 12 months Post-Exchange ]
    Time to Completion (expand-to-implant exchange)

  4. Total number of OR procedures [ Time Frame: 12 month follow-up visit ]
    Procedural Attributes: Total number of OR procedures

  5. Total number of visits [ Time Frame: 12 month follow up visit ]
    Procedural Attributes: Total number of ("in office" and OR procedures)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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)
More Information

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01959867     History of Changes
Other Study ID Numbers: TEI-BR-001
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by Integra LifeSciences Corporation:
mastectomy
breast reconstruction
bovine
ADM
breast cancer
breast implants
breast expanders
radiation therapy