Regenerative Tissue Matrix for Breast Reconstruction

1. Describe the experimental design/methodology.Prospective consecutive case series.

2. Outline the protocol, corresponding it to the specific aims; identify the data or
endpoints to be analyzed to reach the specific aims.

1. The first 3 candidates will serve as the prototypes for the model. There may be
some unanticipated modifications to the setup, patient care, imaging or data
analysis. We plan to follow these 3 cases more deliberately and not proceed until
all 3 are followed for at least 3 months. After these 3 cases, we anticipate the
rest will proceed more smoothly. Placement of the clips to provide the most data
is the primary question for these 3 cases.

The above schematic shows the presumed change is Alloderm size and shape post
expansion and corresponding change in location of the vessel clips. The inferior
borders is the fixed point. By positioning the clips at regular intervals along
the top border, we can measure transverse and horizontal changes. The timing of
ultrasound studies is designed to coincide with when these changes are most likely
to be visualized during the postoperative period. We may change the dates of the
studies. We do not anticipate the the total number of studies will increase
because changes after full expansion (completed by postoperative week 4) are
slower and smaller in magnitude.

2. 30 patients enrolled in the study will be studied for position of the metallic
markers on postoperative day 1, week 4, month 6, month 12. The location of each
clip relative to the fixed anchor point will be recorded and each timepoint. The
fixed anchor point is the medial-inner attachment point of the Alloderm® to the
chest wall fascia. This is the most inferior/medial point of the Alloderm® tissue
matrix. With expansion of the breast expander the chest wall fascia does not move.
Only the overlying skin, pectoralis muscle and Alloderm stretch in response to
breast prosthesis expansion. We can therefore track movement of the clips embedded
in the matrix over time. For each clip we can develop a best fit curve for the 30
subjects studied. This will allow us to develop a mathematical model of the final
position and shape of the reconstructed breast at one year out. This model will be
compared to existing mathematical models for breast tissue expanders (Mentor Corp.

3. A standardized validated questionnaire Breast-Q is a patient reported outcomes
data instrument. The Breast-Q is conceptually grounded in patient perceptions,
able to span the continuum of impact of surgery or validated against appropriate
psychometric benchmarks. It allows for quantification of patient satisfaction and
health-related quality of life experienced by women undergoing breast surgery. The
questionnaire will be administered preoperative, one month postoperative and one
year postoperative.

The BREAST-Q scoring software, QScore, gives clinicians and researchers a simple and
accurate way to analyze their data. It features a powerful scoring engine based on RUMM
2020; a data analyzing program developed by Rasch Unidimensional Measurement Models
Laboratory in Perth, Australia.

Each pre and postoperative BREAST-Q module comes with a Microsoft Excel template. The
templates help to organize your data for import into the QScore program. Once imported,
QScore automatically transforms your raw data into summary scores ranging from 0 (very
dissatisfied) to 100 (very satisfied) for each scale.

3. Discuss potential limitations and difficulties in the protocol. Potential limitations
include displacement of the vessel clips. If this happens, the patient's results and
aesthetic outcome are not compromised. The clips do not cause any harm. These patients
will be followed by standard of care protocol but removed from the study.

4. Provide a tentative schedule for conducting and completing this project and, if
applicable, the multicenter study.

The patients will be seen in the office at study enrollment and post surgery at one
week, one month, six months and one years for evaluation ultrasound study. The Breast Q
questionnaire will be completed preoperatively and then after surgery at one month and
one year. one month and one year post surgery. We anticipated all patients enrolled
within 6 months of study initiation. Total project should less than 2 years after last
patient enrolled.

5. Data collection: Submit a copy of the data collection tool or list the data fields to
be collected (review IRB policy, Access to Medical Records for Research on intranet at
http://henry.hfhs.org).

Data entry points that will be collected include: The patient's name, age, history of
steroid use, past medical history, date of surgery, size of graft used, thickness of the
graft used. Also implant size, pre-surgery bra size, distance from each clip to
inferiolateral anchor point on ultrasound.

7. DATA ANALYSIS: Describe the analysis of the data and relate this to the specific aims.
Describe the statistical analysis in detail (referral to analysis by a multicenter sponsor
is not acceptable). The Committee recommends free consultation with the Division of
Biostatistics and Research Epidemiology.

There are two types of outcome measurements: the alloderm increased size and stardardized
validated questionnaire. We will compare the difference between baseline and each time point
after implant. For the alloderm increased size, the student paired-t statistic wil be used
to test if there is any stretch in size. For questionnaire outcome, one-sample wilcoxon rank
sum test will be used to test the difference in patient satisfication. Bonferrnoi correction
is used for multiple comparison and the familywise type I error rate is set at 0.05.

Inclusion Criteria:

Inclusion of all females from ages 18 and older who undergoing prosthetic breast
reconstruction and will require alloderm for lower pole reconstruction.-

Exclusion Criteria:

Exclusion criteria include perioperative radiation. History of allergic reaction to the
allograft or its components or the metallic clips.