Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
|Breast Cancer Mastectomy||Device: AlloDerm RTU Device: SurgiMend PRS||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
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.Masking: Participant
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: 3 years ]To determine the complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products. Time points include: 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.
- Aesthetic Evaluation [ Time Frame: 3 years following permanent implant placement. ]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. Breast-Q examination is on a scale of 25-100 with 25 questions on a scale of 1-4 where 1 is very dissatisfied and 4 is very satisfied.
|Study Start Date:||September 2012|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781299
|United States, Pennsylvania|
|UPMC Center for Innovation in Restorative Medicine|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Kenneth Shestak, MD||University of Pittsburgh|