Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
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.
Device: AlloDerm RTU
Device: SurgiMend PRS
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU|
- Complication Rates [ Time Frame: After first procedure: 10-14 days, then 2, 4, 6, and 10 weeks after drain removal; After second procedure: 1-2 weeks, 6 weeks, 1 year, and 3 years ] [ Designated as safety issue: No ]To determine the overall complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products.
- Economic Evaluation [ Time Frame: End of Study Participation ] [ Designated as safety issue: No ]At the completion of the Aesthetic Evaluation records will be evaluated to ascertain the overall cost of ADMs used.
- Aesthetic Evaluation [ Time Frame: 6 weeks, 1 year, and 3 years following permanent implant placement. ] [ Designated as safety issue: No ]Initial aesthetic evaluation will occur at approximately 6 weeks after permanent implant placement. Re-evaluation will occur at 1 and 3 years following permanent implant placement. This will involve physical examination, 2D photographs, and patient Breast-Q self-examination.
- ADM Biopsy [ Time Frame: Approximately 12 weeks after ADM implantation (at time of second operative procedure) ] [ Designated as safety issue: No ]Biopsies are taken at time of permanent implant placement. A semi-quantitative scoring system will be used to evaluate histological characteristics, such as capsule formation, inflammation, presence of polymorphonuclear cells, giant cells, plasma cells and/or degradation of material.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: AlloDerm RTU
Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
|Device: AlloDerm RTU|
Active Comparator: SurgiMend PRS
Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
|Device: SurgiMend PRS|
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.
|Contact: Peter W Adams, BSfirstname.lastname@example.org|
|United States, Pennsylvania|
|UPMC Center for Innovation in Restorative Medicine||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Sub-Investigator: Peter W Adams, BS|
|Sub-Investigator: Paul Afrooz, MD|
|Sub-Investigator: Autumn Aul, PA-C|
|Sub-Investigator: Jacqueline Bliley|
|Sub-Investigator: Spencer Brown, PhD|
|Sub-Investigator: Carolyn De La Cruz, MD|
|Sub-Investigator: Michael Gimbel, MD|
|Sub-Investigator: Carlynn Graves, BS, CCRC|
|Sub-Investigator: Russell Kling|
|Sub-Investigator: Kacey Marra, PhD|
|Sub-Investigator: Louise Martin, RN, BSN, CCRC|
|Sub-Investigator: Nancy McCormick, MS, CCRC|
|Sub-Investigator: Jenelle Mock, RN, BSN|
|Sub-Investigator: Vu Nguyen, MD|
|Sub-Investigator: J. Peter Rubin, MD|
|Sub-Investigator: Patsy Simon, RN, BS, CCRC|
|Sub-Investigator: Kelly Snyder, PA-C|
|Sub-Investigator: Wendy Wakefield, CRNP|
|Principal Investigator:||Kenneth Shestak, MD||University of Pittsburgh|