Breast Cancer, Mastectomy
Conditions
Keywords
Breast Cancer, Mastectomy, Immediate reconstruction
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.
Interventions
DEVICEAlloDerm RTU
DEVICESurgiMend PRS
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rates | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic Evaluation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AlloDerm RTU Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
AlloDerm RTU | 4 |
| SurgiMend PRS Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
SurgiMend PRS | 5 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | AlloDerm RTU | SurgiMend PRS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 8.8 | 42 years STANDARD_DEVIATION 3.9 | 48.7 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 9 Participants |
| Region of Enrollment United States | 4 participants | 5 participants | 9 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
Primary
Complication Rates
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.
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AlloDerm RTU | Complication Rates | 4 Participants |
| SurgiMend PRS | Complication Rates | 3 Participants |
Secondary
Aesthetic Evaluation
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.
Time frame: 3 years following permanent implant placement.
Population: discrepancy is caused by funding ending and no data was collected from SurgiMend arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AlloDerm RTU | Aesthetic Evaluation | 83.5 units on a scale |