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Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

NCT03145337 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2018-09-19

No results posted yet for this study

Summary

Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two allograft dermal matrices (ADMs) currently in use for tissue assisted immediate post-mastectomy breast reconstruction.

Conditions

  • Breast Reconstruction

Interventions

BIOLOGICAL

FlexHD ADM (Cohort A)

Tissue assisted breast reconstruction with FlexHD pliable perforated ADM

BIOLOGICAL

AlloDerm RTU ADM (Cohort B)

Tissue assisted breast reconstruction with AlloDerm RTU perforated ADM

Sponsors & Collaborators

  • Musculoskeletal Transplant Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-02-28
Completion
2019-05-31

Countries

  • United States

Study Locations

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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 NCT03145337 on ClinicalTrials.gov