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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SurgiMend® PRS (ADM)

Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).

Group Type EXPERIMENTAL

SurgiMend® PRS

Intervention Type DEVICE

Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).

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).

Group Type OTHER

No Intervention

Intervention Type OTHER

Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).

Interventions

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SurgiMend® PRS

Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).

Intervention Type DEVICE

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).

Intervention Type OTHER

Other Intervention Names

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ADM, acellular dermal matrix

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No