Compare Outcomes Between Two Acellular Dermal Matrices

A Single-Blinded Randomized Prospective Trial to Compare Outcomes Between Two Acellular Dermal Matrices Used for Immediate, Post-Mastectomy Breast Reconstruction

This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm Allograft Dermis (RTI Surgical®, Inc.). These are the thinnest versions of acellular dermal matrices (ADM) offered by both vendors and can be used for post-mastectomy breast reconstruction. Alloderm RTU medium has a thickness of 1.6±0.4 mm, while Cortiva 1mm Allograft Dermis has a thickness of 1.0±0.2 mm. In the context of breast reconstruction, these ADMs are used in the same manner. They may be inserted with a tissue expander immediately after skin- or nipple-sparing mastectomy. The investigators will examine breast-reconstruction associated complication rates, pre- and post-operative patient reported outcomes using the Breast Q, and physician reimbursement as well as direct hospital costs. The endpoint will be either exchange of the tissue expander for a permanent breast implant or autologous flap, explantation due to patient preference, development of a complication, or less common reasons. The investigators propose that Cortiva 1mm Allograft Dermis and Alloderm RTU will have equivalent complication and patient reported outcome rates as well as physician reimbursement, but that direct hospital cost will be less with Cortiva 1mm Allograft Dermis.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Alloderm RTU; Procedure: Skin or nipple-sparing mastectomy; Other: Breast Q; Procedure: Surgery; Other: Cortiva 1mm Allograft Dermis

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sex: Females
• Age: 22 to 70 years old
• Preoperative surgical plan: Immediate placement subpectoral (subpectoral and postpectoral are synonymous) tissue expander with ADM or Immediate placement prepectoral tissue expander or implant with ADM
• Mastectomy type: Skin-sparing or nipple-sparing mastectomy with or without sentinel lymph node biopsy; may be unilateral or bilateral mastectomy
• Able to understand and willing to sign IRB approved written informed consent document.

Exclusion Criteria:

-Pregnant and/or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Alloderm RTU; Prior to the date of mastectomy, the BREAST Q patient-reported outcome survey will be administered for routine clinical care purposes. It may occur before or after enrollment.; On the day of surgery, patients will receive standardized preoperative care, a skin- or nipple-sparing mastectomy from an experienced surgical breast oncologists and immediate tissue expander breast reconstruction with Dr. Myckatyn or Dr. Tenenbaum. Uniform operative techniques will be used in both treatment groups. All patients will receive either a 16x8 cm (128 sq cm) ADM graft for postpectoral reconstruction or 16x20 cm (320 sq cm) for prepectoral reconstruction. Patients randomized to Group A will receive Alloderm RTU; A post-operative version of the Breast Q validated in patients who have received tissue expanders will be administered between 1 and 3 months after tissue expander insertion, and again prior to exchange for an implant or flap (or at time of patient-requested removal	Other: Alloderm RTU; -Most commonly used acellular dermal matrices; Procedure: Skin or nipple-sparing mastectomy; -Standard of care; Other: Breast Q; 15 questions; 10 questions in Part A asking how has the patient been feeling in past 24 hours, answers range from 0-10 with 0=none of the time and 10=all of the time; Part B has 5 questions asking patient if she has had any of the following in the last 24 hours, answers ranging from 0-10 with 0=none of the time and 10=all of the time; Procedure: Surgery; To address the tissue expander; Standard of care
Experimental: Group B: Cortiva 1mm Allograft Dermis; Prior to the date of mastectomy, the BREAST Q patient-reported outcome survey will be administered for routine clinical care purposes. It may occur before or after enrollment.; On the day of surgery, patients will receive standardized preoperative care, a skin- or nipple-sparing mastectomy from an experienced surgical breast oncologists and immediate tissue expander breast reconstruction with Dr. Myckatyn or Dr. Tenenbaum. Uniform operative techniques will be used in both treatment groups. All patients will receive either a 16x8 cm (128 sq cm) ADM graft for postpectoral reconstruction or 16x20 cm (320 sq cm) for prepectoral reconstruction. Patients randomized to Group B will receive Cortiva 1mm Allograft Dermis; A post-operative version of the Breast Q validated in patients who have received tissue expanders will be administered between 1 and 3 months after tissue expander insertion, and again prior to exchange for an implant or flap (or at time of patient-requested removal	Procedure: Skin or nipple-sparing mastectomy; -Standard of care; Other: Breast Q; 15 questions; 10 questions in Part A asking how has the patient been feeling in past 24 hours, answers range from 0-10 with 0=none of the time and 10=all of the time; Part B has 5 questions asking patient if she has had any of the following in the last 24 hours, answers ranging from 0-10 with 0=none of the time and 10=all of the time; Procedure: Surgery; To address the tissue expander; Standard of care; Other: Cortiva 1mm Allograft Dermis; -Tutoplast processed dermis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of premature tissue expander (TE) removal	All participants meeting the eligibility criteria who have signed a consent form and have a skin- or nipple-sparing mastectomy and immediate tissue expander breast reconstruction will be included in the analyses of the primary study endpoint.; A breast with the TE removed before planned exchange to a permanent breast implant is considered to have had a premature TE removal	Up to 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction as measured by Breast Q	Each domain contains separate modules that investigate physical, psychosocial, and sexual well-being as well as their satisfaction with their care, breasts, and overall outcome.; It also investigates patient expectations in the preoperative questionnaire, and degree to which expectations were met in the post-operative version.; Each module generates a Q-score on a 0-100 scale that can be used for quantitative analysis to enable statistical comparison of the pre- to the post-operative state.	Up to 15 months
Health related quality of life as measured by Breast Q	Each domain contains separate modules that investigate physical, psychosocial, and sexual well-being as well as their satisfaction with their care, breasts, and overall outcome.; It also investigates patient expectations in the preoperative questionnaire, and degree to which expectations were met in the post-operative version.; Each module generates a Q-score on a 0-100 scale that can be used for quantitative analysis to enable statistical comparison of the pre- to the post-operative state.	Up to 15 months
Duration of drain use	-The number of days a drain is used after surgery	Up to 15 months
Incidence of analgesic use for pain	-Outpatient analgesia beyond preoperative analgesic requirements will be recorded, and will include no pain medicine, celecoxib, gabapentin, acetaminophen, hydrocodone, oxycodone, OxyContin, ibuprofen, hydromorphone, cyclobenzaprine, and methadone.	Up to 15 months
Incidence of infection as measured by presence or absence of cellulitis	-The number of participants who experience cellulitis	Up to 15 months
Incidence of non-infectious complications	-These will include seroma (and method(s) of seroma diagnosis), incisional dehiscence, necrosis of the mastectomy skin flap, dehiscence of the ADM from the chest wall or pectoralis muscle, hematoma, or a pathologic (grade III or IV) capsular contracture.	Up to 15 months
Nature of second surgery as measured by type of surgery enrolled patients undergo to address their tissue expander after its initial insertion	-Document type of second surgery each participants has after their initial tissue expander	Up to 15 months
Degree of acellular dermal matrices (ADM) incorporation	-A qualitative scale, from 1-4 will be used to quantity ADM incorporation. This will be recorded upon inspection of the ADM at the time that the tissue expander is readdressed.	Up to 15 months
Comparison of direct hospital costs	-These are available through Barnes hospital and will be normalized to Medicare rates by conversion from relative value units (RVU) due to heterogeneity in payer mix. Line item costs as well as patient-level data will not be available due to the proprietary nature of these products. However, normalized, aggregate patient data for the cycle of care in each study arm (Alloderm RTU vs Cortiva 1mm Allograft Dermis) is available and will be calculated. "Direct costs" are those that can be traced directly to a department, product or service, excluding overhead costs, and thus reflect the hospital's assessment of the cost it incurred providing the specific services and supplies used by the patients. All breast reconstruction related costs performed by Barnes, or Barnes West County hospital from the first surgery up until immediately before the second surgery will be included.	Up to 15 months
Comparison of physician reimbursements	-These are available through the Department of Surgery and will be normalized to Medicare rates by conversion from relative value units (RVU) due to heterogeneity in payer mix. Line item costs as well as patient-level data will not be available due to the proprietary nature of these products. However, normalized, aggregate patient data for the cycle of care in each study arm (Alloderm vs Cortiva 1mm Allograft Dermis) is available and will be calculated. All breast reconstruction related costs billed by Washington University Physicians from the first surgery up until immediately before the second surgery will be included.	Up to 15 months
Amount of tissue expander fill	-This is breast-level data since the left and right side may differ in bilateral reconstruction cases. The investigators already track tissue expander fills as part of the electronic medical record. The amount of tissue expander fill during surgery and device type are recorded in the operative record.	At the time of surgery
Immediate implant type as measured by volume (cc)		At the time of surgery
Immediate implant type as measured by manufacturer		At the time of surgery
Immediate implant type as measured by shape		At the time of surgery
Immediate implant type as measured by fill		At the time of surgery
Immediate implant type as measured by surface characteristics		At the time of surgery

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: RTI Surgical

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2017
• Primary Completion (Actual): October 27, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 201608168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No