Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU

Completed · Phase 4

Conditions studied: Breast Cancer, Mastectomy

In brief

The purpose of this study is to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of these two treatment options.

Key facts

Study ID

NCT01781299

Run by

University of Pittsburgh

People needed

9

Starts

2012-09-01

Expected to finish

2015-09-01

Last updated by the study team

2017-05-12

Who can join

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

You may qualify if…

• Subject's with ability to provide informed consent.
• Subjects greater than 18 years old
• Subjects to undergo an immediate tissue expander reconstruction following mastectomy; and
• Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits.

You may not qualify if…

• Subjects less than 18 years of age
• Subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of ADM product
• Pregnancy
• Bovine allergy

Where it is running

• UPMC Center for Innovation in Restorative Medicine — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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