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

January 6, 2017 updated by: Integra LifeSciences Corporation

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • ADM, acellular dermal matrix
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months Post-Exchange
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.
12 months Post-Exchange

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No. Capsule Procedures
Time Frame: 12 months Post-Exchange
Number of capsule procedures performed
12 months Post-Exchange
Cosmetic Assessment
Time Frame: 12 months Post-Exchange
Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs)
12 months Post-Exchange
Time to Completion
Time Frame: 12 months Post-Exchange
Time to Completion (expand-to-implant exchange)
12 months Post-Exchange
Total number of OR procedures
Time Frame: 12 month follow-up visit
Procedural Attributes: Total number of OR procedures
12 month follow-up visit
Total number of visits
Time Frame: 12 month follow up visit
Procedural Attributes: Total number of ("in office" and OR procedures)
12 month follow up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (ESTIMATE)

October 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEI-BR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on SurgiMend® PRS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe