The Use of Complete AlloDerm® Coverage in Two-stage Tissue Expansion and Implant Placement in the Subcutaneous (Pre-pectoral) Plane: a Prospective Pilot

Study participants meeting inclusion criteria will be enrolled prior to surgery. Once the patient has been seen by one of the Institutional Review Board (IRB)-approved study physicians at the initial clinic visit and informed consent has been obtained, pre-study patient-reported outcome (PRO) questionnaires will be distributed and collected by one of the IRB-approved healthcare providers (i.e. medical assistant, nurse, nurse-practitioner, or plastic surgeon). These questionnaires include the Pain Visual Analog Scale, the Patient Pain Assessment Questionnaire which assesses static and dynamic pain as well as nausea and interference with sleep, the Subjective Pain Survey, the preoperative Breast-Q: Reconstruction Module, the SF-36, and the Brief Pain Inventory-Short Form. Participants will then be asked to complete a general patient history form.

Patients will undergo bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage. Patients who are determined to be poor surgical candidates intra-operatively will be excluded from the study and receive standard of care reconstruction. All patient-specific surgical details will be recorded intra-operatively. See Figure 1 for a schematic of the first stage of reconstruction: bilateral mastectomy and tissue expander placement.

Following the surgery, postoperative pain will be assessed by the Pain Visual Analog Scale (VAS), the Patient Pain Assessment Questionnaire, and the Brief Pain Inventory-Short Form (BPI-SF); pain medication/opioid use and nausea/vomiting will be assessed by the Postoperative nausea and vomiting (PONV) Intensity Scale; and adverse events (AEs)/serious adverse events (SAEs) and the occurrence of complications (seroma, hematoma, cellulitis, and infection requiring expander removal) will be assessed by staff during the hospital stay (Day 1, Day 2, Day 3) and on Day 7 (±2 days) when participants return to clinic for the first follow-up visit after mastectomy and tissue expander placement. At this visit on Day 7, an updated medical history will be completed, pain medication and opioid use will be recorded, and participant complications/AEs/SAEs assessed. In order to minimize missing data, participants will be educated by an IRB-approved member to complete all possible questionnaire items. Furthermore, in order to avoid expectancy-bias, study team members will ensure that patients complete the PRO questionnaires before meeting with study healthcare providers for all postoperative follow-up appointments. Following the completion of all assessments on Day 7, patients will undergo initiation of tissue expander expansion carefully recording the rate and volume of fill.

Longer-term quality-of-life/health outcomes assessments will be performed on postoperative Day 30 (±4 days) and Day 60 (±7 days) after the initiation of tissue expander expansion. During these visits, pain scores (Pain Visual Analog Scale, Patient Pain Assessment Questionnaire, and Brief Pain Inventory-Short Form), pain medication/opioid use, postoperative Breast-Q, and SF-36 questionnaires will be administered. Day 60 follow-up is included as a tertiary endpoint to capture differences in residual pain. Patients will be asked to complete the same questionnaires as at the Day 30 follow-up.

Following final reconstruction with tissue expander exchange for permanent implant, typically three months after mastectomy and tissue expander placement, all PRO questionnaires, postoperative static and dynamic pain, nausea/vomiting/opioid use, short-term changes in Quality of Life, complication rates, average hospital length of stay and residual pain will be assessed. Additionally, on Day 30, and Day 60 after permanent implant placement patients will be photographed comparing the breasts at rest and with pectoralis muscle flexion to assess for breast animation deformity using the Spear 4-point grading system. They will then be imaged using "VECTRA® XT 3D" digital imaging technology ("CANFIELD Scientific", Inc.) on Day 60. Differences in breast volume, surface area, shape, size, contour, and symmetry will be evaluated using the "VECTRA® XT" Analysis Module software. Day 60 follow-up is included as a tertiary endpoint to capture differences in cosmetic result and residual pain after final reconstruction. Patients will be asked to complete the same questionnaires as at the Day 30 follow-up. See Figure 2 for a schematic of the second stage of reconstruction: tissue expander exchange for permanent implant.