Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
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| ClinicalTrials.gov Identifier: NCT01781299 |
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Recruitment Status :
Completed
First Posted : January 31, 2013
Results First Posted : May 12, 2017
Last Update Posted : May 12, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Mastectomy | Device: AlloDerm RTU Device: SurgiMend PRS | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 9 participants |
| 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: | Single (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 |
| Study Start Date : | September 2012 |
| Actual Primary Completion Date : | September 2015 |
| Actual Study Completion Date : | September 2015 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: AlloDerm RTU
Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
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Device: AlloDerm RTU |
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Active Comparator: SurgiMend PRS
Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
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Device: SurgiMend PRS |
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781299
| United States, Pennsylvania | |
| UPMC Center for Innovation in Restorative Medicine | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Kenneth Shestak, MD | University of Pittsburgh |
| Responsible Party: | Ken Shestak, Principal Investigator, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01781299 |
| Other Study ID Numbers: |
PRO11020226 |
| First Posted: | January 31, 2013 Key Record Dates |
| Results First Posted: | May 12, 2017 |
| Last Update Posted: | May 12, 2017 |
| Last Verified: | May 2017 |
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Breast Cancer Mastectomy Immediate reconstruction |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |