Compare Outcomes Between Two Acellular Dermal Matrices

May 3, 2023 updated by: Washington University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of premature tissue expander (TE) removal
Time Frame: Up to 15 months
  • 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction as measured by Breast Q
Time Frame: Up to 15 months
  • 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
Time Frame: Up to 15 months
  • 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
Time Frame: Up to 15 months
-The number of days a drain is used after surgery
Up to 15 months
Incidence of analgesic use for pain
Time Frame: Up to 15 months
-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
Time Frame: Up to 15 months
-The number of participants who experience cellulitis
Up to 15 months
Incidence of non-infectious complications
Time Frame: Up to 15 months
-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
Time Frame: Up to 15 months
-Document type of second surgery each participants has after their initial tissue expander
Up to 15 months
Degree of acellular dermal matrices (ADM) incorporation
Time Frame: Up to 15 months
-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
Time Frame: Up to 15 months
-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
Time Frame: Up to 15 months
-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
Time Frame: At the time of surgery
-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)
Time Frame: At the time of surgery
At the time of surgery
Immediate implant type as measured by manufacturer
Time Frame: At the time of surgery
At the time of surgery
Immediate implant type as measured by shape
Time Frame: At the time of surgery
At the time of surgery
Immediate implant type as measured by fill
Time Frame: At the time of surgery
At the time of surgery
Immediate implant type as measured by surface characteristics
Time Frame: At the time of surgery
At the time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RTI Surgical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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