Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

Status unconfirmed · Not applicable

Conditions studied: Breast Reconstruction

In brief

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.

Key facts

Study ID

NCT03145337

Run by

Musculoskeletal Transplant Foundation

People needed

224

Starts

2017-07-01

Expected to finish

2019-05-01

Last updated by the study team

2018-09-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo immediate, post-mastectomy, tissue assisted breast reconstruction, Reconstruction shall be either one-stage (direct-to-implant) or two-stage, unilateral or bilateral, prophylactic or therapeutic
• Females at least 18 years of age
• Non-smokers, former smokers and/or smokers who have not smoked within 1 month before surgery, and who agree to not smoke or utilize e-cigarettes during the post-operative period
• Have signed a written informed consent
• Have the ability to understand and comply with the requirements and follow-up time points of the study

You may not qualify if…

• Previous breast surgery with the exception of biopsy
• Previous radiation treatment in either breast at any time
• Undergoing autologous breast reconstruction
• Pre-pectoral implant placement
• Undergoing delayed reconstruction
• Requiring Wise pattern reduction of mastectomy skin flap
• History of chronic steroid use within the past 6 months
• History of HIV positive
• Previous organ transplant
• Pregnant or lactating females
• Clinically significant systemic disease, as determined by the investigator, which could affect study participation or study results

Where it is running

• Northwestern University Medical Center — Chicago, Illinois, United States
• NorthShore Health Systems — Evanston, Illinois, United States
• Louisiana State Health Science Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Faulkner Brigham & Women's Hospital — Jamaica Plain, Massachusetts, United States
• New York University Langone Medical Center — New York, New York, United States
• Harris Methodist Southlake Hospital — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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