Breast CancerPhase 2NCT02891759
Compare Outcomes Between Two Acellular Dermal Matrices
A Phase 2 study testing Alloderm RTU, Cortiva 1mm Allograft Dermis and Skin or nipple-sparing mastectomy in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Alloderm RTU, Cortiva 1mm Allograft Dermis and Skin or nipple-sparing mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2017to 27 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -Pregnant and/or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Alloderm RTU, Cortiva 1mm Allograft Dermis, Skin or nipple-sparing mastectomy, Breast Q, Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alloderm RTUOther
-Most commonly used acellular dermal matrices
Cortiva 1mm Allograft DermisOther
-Tutoplast processed dermis
Skin or nipple-sparing mastectomyProcedure or surgery
-Standard of care
Breast QOther
- 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
SurgeryProcedure or surgery
- To address the tissue expander
- Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Group A: Alloderm RTU | Experimental | * 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 Receives: Other: Alloderm RTU; Procedure: Skin or nipple-sparing mastectomy; Other: Breast Q; Procedure: Surgery |
| Group B: Cortiva 1mm Allograft Dermis | Experimental | * 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 Receives: Other: Cortiva 1mm Allograft Dermis; Procedure: Skin or nipple-sparing mastectomy; Other: Breast Q; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 15 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: Up to 15 months
Duration of drain use
-The number of days a drain is used after surgery
Measured: 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.
Measured: Up to 15 months
Incidence of infection as measured by presence or absence of cellulitis
-The number of participants who experience cellulitis
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of surgery
Immediate implant type as measured by volume (cc)
Measured: At the time of surgery
Immediate implant type as measured by manufacturer
Measured: At the time of surgery
Immediate implant type as measured by shape
Measured: At the time of surgery
Immediate implant type as measured by fill
Measured: At the time of surgery
Immediate implant type as measured by surface characteristics
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start31 Jan 2017
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- RTI Surgical
- Responsible party
- Sponsor
- Investigators
- Terence M Myckatyn, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891759
- Sponsor's protocol ID
- 201608168
- Status last verified
- May 2023
- First submitted
- 31 Aug 2016
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blinded Randomized Prospective Trial to Compare Outcomes Between Two Acellular Dermal Matrices Used for Immediate, Post-Mastectomy Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02891759
- Acronym / sponsor ID
- 201608168
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- RTI Surgical
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Alloderm RTU | Experimental | Other: Alloderm RTU, Procedure: Skin or nipple-sparing mastectomy, Other: Breast Q, Procedure: Surgery* 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 |
| Group B: Cortiva 1mm Allograft Dermis | Experimental | Other: Cortiva 1mm Allograft Dermis, Procedure: Skin or nipple-sparing mastectomy, Other: Breast Q, Procedure: Surgery* 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 |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -Pregnant and/or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alloderm RTU-Most commonly used acellular dermal matrices | Other | Group A: Alloderm RTU |
| Cortiva 1mm Allograft Dermis-Tutoplast processed dermis | Other | Group B: Cortiva 1mm Allograft Dermis |
| Skin or nipple-sparing mastectomy-Standard of care | Procedure or surgery | Group A: Alloderm RTU, Group B: Cortiva 1mm Allograft Dermis |
| 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 | Other | Group A: Alloderm RTU, Group B: Cortiva 1mm Allograft Dermis |
| Surgery* To address the tissue expander * Standard of care | Procedure or surgery | Group A: Alloderm RTU, Group B: Cortiva 1mm Allograft Dermis |
Primary outcome
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
16 secondary outcomes
Patient satisfaction as measured by Breast Q
Time frame: Up to 15 months
Health related quality of life as measured by Breast Q
Time frame: Up to 15 months
Duration of drain use
Time frame: Up to 15 months
Incidence of analgesic use for pain
Time frame: Up to 15 months
Incidence of infection as measured by presence or absence of cellulitis
Time frame: Up to 15 months
Incidence of non-infectious complications
Time frame: 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
Degree of acellular dermal matrices (ADM) incorporation
Time frame: Up to 15 months
Comparison of direct hospital costs
Time frame: Up to 15 months
Comparison of physician reimbursements
Time frame: Up to 15 months
Amount of tissue expander fill
Time frame: At the time of surgery
Immediate implant type as measured by volume (cc)
Time frame: At the time of surgery
Immediate implant type as measured by manufacturer
Time frame: At the time of surgery
Immediate implant type as measured by shape
Time frame: At the time of surgery
Immediate implant type as measured by fill
Time frame: At the time of surgery
Immediate implant type as measured by surface characteristics
Time frame: At the time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terence M Myckatyn, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alloderm RTU, Cortiva 1mm Allograft Dermis and Skin or nipple-sparing mastectomy in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of premature tissue expander (TE) removal (time frame: Up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.