Clinical trial NCT01781299: Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
Official title: Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Mastectomy
Keywords: Breast Cancer
Mastectomy
Immediate reconstruction
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We are looking at 2 products called Acellular Dermal Matrix (ADM) implant to evaluate the outcomes of 2 specific ADM products: SurgiMend PRS and AlloDerm RTU.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In recent years, acellular dermal matrix (ADM) products have increasingly been utilized in breast reconstruction in order to protect the implant from exposure under a thin mastectomy skin flap while also allowing better control of the inframammary fold and, therefore, a better cosmetic result. In current clinical practice, cost is a factor in considering procedures and adjunct products. AlloDerm RTU and SurgiMend PRS are dissimilar in cost, with AlloDerm RTU more costly by 30-50%, and it is unclear if they are similar in efficacy.

This study will be a prospective, randomized-to-test article (ADM), controlled, blinded-to-aesthetic/biopsy specimen evaluator trial. It will provide a way to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS product as well as the relative economics of these two treatment options. Study subjects will only be randomized to one of two surgical mesh products. Patient information including age, BMI, smoking history, tumor size and location, preoperative bra cup size, mastectomy specimen weight, mastectomy method, plastic surgeon, mastectomy surgeon, quality of skin, tissue expander type and maximal volume, intra-operative fill volume, gel/saline implant type and size, chemotherapy, and radiation therapy will be summarized.

Eligibility criteria: Inclusion Criteria:

1. Subject's with ability to provide informed consent.
2. Subjects greater than 18 years old
3. Subjects to undergo an immediate tissue expander reconstruction following mastectomy; and
4. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Complication Rates
timeFrame: 3 years
Secondary outcomes:
measure: Aesthetic Evaluation
timeFrame: 3 years following permanent implant placement.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Center for Innovation in Restorative Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kenneth Shestak, MD
role: PRINCIPAL_INVESTIGATOR
References:
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