Breast Cancer Clinical Trial
Official title:
Post-operative Outcomes as Clinical Evidence for Soft Tissue Reinforcement: a Prospective Cohort Study.
The use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction, both in single-stage direct-to-implant (DTI) and staged tissue expander placement. Nearly half of all breast reconstruction procedures performed within the United States have incorporated ADM. Despite such widespread acceptance among both patients and plastic surgeons, manufacturers of ADM face difficulties in obtaining approval by the Food and Drug Administration (FDA) for use of their product as a medical device in breast reconstructions. ADM is defined as banked tissue and, as such, is approved for use as tissue support. Under section 510k of the Food, Drug and Cosmetic Act, ADM must exhibit "soft tissue reinforcement of integument" to be considered a medical device, a criterion that has yet to be physiologically or clinically defined. This distinction precludes the development and manufacture of xenogeneic ADM. The aim of this research is to compare reconstruction outcomes between ADM and Vicryl, a non-ADM control that is hydrolyzed and degraded within 6-8 weeks after surgery. The investigators propose a prospective cohort study to determine whether post-operative outcomes provide clinical and anatomic evidence for soft tissue reinforcement within the ADM group.
This study will measure objective clinical endpoints in DTI breast reconstruction. A total of
152 patients (76 for both ADM and non-ADM cohorts) will be followed in a prospectively
recorded database. The clinical care of the patient will be safe-guarded to proceed entirely
unaffected by the study. Enrollment will be limited to patients of Dr. Liao and Dr. William
Austen at the Massachusetts General Hospital who are scheduled to undergo immediate, DTI
breast reconstruction. Patients may undergo immediate, DTI breast reconstruction if they have
mastectomies for the purpose of either removing breast cancer or prophylactic removal of the
breasts following diagnosis of genetic predisposition for breast cancer based on family
history or genetic testing. All patients will be women. The age minimum is 18 years. There is
no age maximum.
The study will involve only recording of data (patient characteristics, clinical data,
reconstructive parameters (size of ADM and implant used), drain placement, number and caliber
of drains, outcomes of surgery). At initial consultation, per the standard routine for Dr.
Liao's patients, digital photographs and 3D photographs will be obtained below the neck,
eliminating any patient identifiers. Patients will be followed per routine care protocol. A
typical patient will be followed weekly for 6 weeks, then at 3 months, 6 months, and 12
months. All photographs are de-identified and taken below the neck, and are kept in a secure
photograph database maintained by the Division of Plastic and Reconstructive Surgery. The
clinical care of the patient adheres strictly to the existing standard of care by the surgeon
(Dr. Liao). The study will involve only the recording of data without any additional
interaction with the patient.
The primary clinical endpoint to be measured is breast form. Secondary clinical endpoints
include: seroma, infection, skin necrosis, wound problems, explantation, and any other minor
or major complications. Breast thickness and landmark positioning will be recorded as
quantitative measures of breast form. The investigators will determine tissue thickness in
the following areas: (a) point of maximal projection, (b) inferior pole of the breast, and
(c) the midpoint between the aforementioned areas, a and b. Measurements will be made using
transcutaneous ultrasound (GE NextGen LOGIQ e R7 compact digital ultrasound). Landmark
mapping will be conducted via Vectra imaging software. The positioning of the nipples and
inframammary fold (IMF) relative to the sternal notch will be determined through a
predetermined Vectra algorithm. Post-operative imaging will be conducted at 6 weeks, 3
months, 6 months, and 12 months. Digital images will provide objective information on
aesthetic outcomes and evidence of ptosis, pseudoptosis, symmetry, chest position, or nipple
position (if nipple sparing) for both cohorts.
In addition to objective clinical outcomes, patient reported outcomes (PRO) will be measured
with the Breast-Q questionnaire. The survey will be administered during the initial consult
(pre-mastectomy module) and then reassessed (post-mastectomy module) at 3 months (early
recovery) and 12 months (late recovery) to track changes in quality of life (QOL). The PRO
will be compared between the ADM and non-ADM cohorts.
The investigators expect to reach the goal of 152 patients within 6 to 12 months, and
complete the study with a minimum of 6 months of follow-up within 24 months.
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