Clinical trial NCT02891759: Compare Outcomes Between Two Acellular Dermal Matrices
Official title: A Single-Blinded Randomized Prospective Trial to Compare Outcomes Between Two Acellular Dermal Matrices Used for Immediate, Post-Mastectomy Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: RTI Surgical
First posted: 2016-09-07
Enrollment: 320
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of premature tissue expander (TE) removal
timeFrame: Up to 15 months
Secondary outcomes:
measure: Patient satisfaction as measured by Breast Q
timeFrame: Up to 15 months
measure: Health related quality of life as measured by Breast Q
timeFrame: Up to 15 months
measure: Duration of drain use
timeFrame: Up to 15 months
measure: Incidence of analgesic use for pain
timeFrame: Up to 15 months
measure: Incidence of infection as measured by presence or absence of cellulitis
timeFrame: Up to 15 months
measure: Incidence of non-infectious complications
timeFrame: Up to 15 months
measure: Nature of second surgery as measured by type of surgery enrolled patients undergo to address their tissue expander after its initial insertion
timeFrame: Up to 15 months
measure: Degree of acellular dermal matrices (ADM) incorporation
timeFrame: Up to 15 months
measure: Comparison of direct hospital costs
timeFrame: Up to 15 months
measure: Comparison of physician reimbursements
timeFrame: Up to 15 months
measure: Amount of tissue expander fill
timeFrame: At the time of surgery
measure: Immediate implant type as measured by volume (cc)
timeFrame: At the time of surgery
measure: Immediate implant type as measured by manufacturer
timeFrame: At the time of surgery
measure: Immediate implant type as measured by shape
timeFrame: At the time of surgery
measure: Immediate implant type as measured by fill
timeFrame: At the time of surgery
measure: Immediate implant type as measured by surface characteristics
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Terence M Myckatyn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: