Clinical trial NCT03195322: Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction
Official title: The Use of Complete AlloDerm® Coverage in Two-stage Tissue Expansion and Implant Placement in the Subcutaneous (Pre-pectoral) Plane: a Prospective Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Postoperative Nausea and Vomiting
Quality of Life
Breast Cancer
Breast Prosthesis; Pain
Keywords: Immediate Breast Reconstruction
Pain Control
Post Mastectomy Pain Control
Acellular Dermal Matrix
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

• To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage.

Secondary Objectives:

* To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale and Brief Pain Inventory-Short Form at Day 1-60 after tissue expander placement
* To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement.
* To describe short-term changes in Quality of Life scores after mastectomy and tissue expander placement.
* To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement.
* To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
* To describe short-term changes in Quality of Life scores after final reconstruction with tissue expander exchange for permanent implant.
* To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
* To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
* To describe average hospital length of stay in patients after final reconstruction with tissue expander exchange for permanent implant.
* To describe the patient's final assessment of pre-pectoral reconstruction from free-form text.

Tertiary Objectives:

• To measure cosmetic result and associated residual pain with Alloderm® reinforcement of breast pocket.

Detailed description: 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.

\*Patients will be called the morning of their Day 7, Day 30, and Day 60 appointments as a reminder. In the event they are unable to attend, every attempt will be made to reschedule within 2, 4, and 7 days, respectively.

Eligibility criteria: Inclusion Criteria:

* Be women, aged 18-75 years.
* Choose bilateral mastectomy (therapeutic or prophylactic) followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.
* Have no inflammatory breast cancers.
* Be aware of the nature of her malignancy.
* Understand the study purpose, requirements, and risks.
* Be able and willing to give informed consent.

Exclusion Criteria:

* Plan to undergo final reconstruction with autologous material.
* Allergies to gentamicin, cefoxitin, lincomycin, vancomycin, or polymixin (antibiotics used in the pre-treatment of AlloDerm®).
* Active connective tissue disease.
* Current smokers.
* History of, or plan to undergo irradiation of the breasts.

Primary outcomes:
measure: Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using Visual Analog Scale (VAS)
timeFrame: Day 1
Secondary outcomes:
measure: Evaluation of Postoperative Dynamic Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
measure: Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS
timeFrame: Day 2, Day 3, Day 7, Day 30, and Day 60
measure: Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using "BPI-SF" questionnaire
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
measure: Level of Postoperative opioid use after Mastectomy and Tissue Expander
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
measure: Number of participants with postoperative vomiting after Mastectomy and Tissue Expander placement using the PONV Intensity Scale
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
measure: Number of participants with postoperative nausea after Mastectomy and Tissue Expander placement using the PONV Intensity Scale
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
measure: Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire
timeFrame: Day 30
measure: Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire
timeFrame: Baseline and Day 30
measure: Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire
timeFrame: Day 7, Day 30
measure: Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire
timeFrame: Day 7, Day 30
measure: Number of participants with any postoperative complication following mastectomy and tissue expander placement based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
measure: Level of Postoperative opioid use after final breast reconstruction
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
measure: Number of participants with postoperative vomiting after final breast reconstruction using the PONV Intensity Scale
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
measure: Number of participants with postoperative nausea after final breast reconstruction using the PONV Intensity Scale
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
measure: Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction with permanent implant by using Breast-Q questionnaire
timeFrame: Day 30, 60
measure: Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using Breast-Q questionnaire
timeFrame: Day 30, 60
measure: Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire
timeFrame: Day 7, Day 30, Day 60
measure: Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire
timeFrame: Day 7-60
measure: Number of participants with any postoperative complication following final breast reconstruction based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
measure: Number of participants with postoperative breast animation deformity assessed by Spear grading system and "VECTRA XT 3D"
timeFrame: Day 7, Day 30, Day 60
measure: Evaluation of Hospital Length of Stay after final reconstruction in days
timeFrame: Day 1-3
measure: Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS)
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
measure: Evaluation of Postoperative Dynamic Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS)
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
measure: Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using BPI-SF
timeFrame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gedge D Rosson, MD
role: PRINCIPAL_INVESTIGATOR
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