Skip to main content
OpenTrials
Completed

NCT Number: NCT02891759

Compare Outcomes Between Two Acellular Dermal Matrices

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

22 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alloderm RTU

Other

-Most commonly used acellular dermal matrices

Cortiva 1mm Allograft Dermis

Other

-Tutoplast processed dermis

Skin or nipple-sparing mastectomy

Procedure

-Standard of care

Breast Q

Other
  • 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

Surgery

Procedure
  • To address the tissue expander
  • Standard of care

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. Duration of drain use

    Time frame: Up to 15 months

    -The number of days a drain is used after surgery

  4. 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.

  5. Incidence of infection as measured by presence or absence of cellulitis

    Time frame: Up to 15 months

    -The number of participants who experience cellulitis

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Immediate implant type as measured by volume (cc)

    Time frame: At the time of surgery

  13. Immediate implant type as measured by manufacturer

    Time frame: At the time of surgery

  14. Immediate implant type as measured by shape

    Time frame: At the time of surgery

  15. Immediate implant type as measured by fill

    Time frame: At the time of surgery

  16. Immediate implant type as measured by surface characteristics

    Time frame: At the time of surgery

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • RTI Surgical

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2016
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.