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

NCT01959867 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-01-10

No results posted yet for this study

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.

Conditions

Interventions

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

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).

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-01-31
Completion
2017-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01959867 on ClinicalTrials.gov