Clinical trial NCT03494244: Evaluation of ADM Soft Tissue Reinforcement
Official title: Post-operative Outcomes as Clinical Evidence for Soft Tissue Reinforcement: a Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Surgery
Surgical Item, Retained
Keywords: acellular dermal matrix
breast reconstruction
efficacy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who undergo 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* direct to implant breast reconstruction

Exclusion Criteria:

* BMI \> 30
* history of smoking within 1 year of enrollment
* previous breast surgery
* malnutrition or cachexia
* breast implant volume ≤ 125 mL or ≥ 700 mL

Primary outcomes:
measure: Change in Tissue thickness (measured in millimeters).
timeFrame: Post-surgical, follow-up intervals extending to one year following reconstruction. Measurements will be performed at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 months.
measure: Change in Anatomic landmark position (measured in centimeters)
timeFrame: Post-surgical, follow-up intervals extending to one year following reconstruction. These cardinal landmarks of breast form and axis length will be collected at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 months.
Secondary outcomes:
measure: Infection
timeFrame: 90 days post-operatively.
measure: Self reported outcomes
timeFrame: Post-surgical, follow-up intervals extending to one year following reconstruction.
Other outcomes:
Locations:
Study officials:
References: