Compare Outcomes Between Two Acellular Dermal Matrices

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891759
• Other study ID #: 201608168
• Status: Completed
• Phase: Phase 2
• Start date: January 31, 2017
• Est. completion date: October 27, 2022

Study information

• Verified date: May 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 27, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Alloderm RTU
-Most commonly used acellular dermal matrices
• Cortiva 1mm Allograft Dermis
-Tutoplast processed dermis

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	RTI Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Duration of drain use	-The number of days a drain is used after surgery	Up to 15 months
Secondary	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
Secondary	Incidence of infection as measured by presence or absence of cellulitis	-The number of participants who experience cellulitis	Up to 15 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Immediate implant type as measured by volume (cc)		At the time of surgery
Secondary	Immediate implant type as measured by manufacturer		At the time of surgery
Secondary	Immediate implant type as measured by shape		At the time of surgery
Secondary	Immediate implant type as measured by fill		At the time of surgery
Secondary	Immediate implant type as measured by surface characteristics		At the time of surgery

External Links

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