Compare Outcomes Between Two Acellular Dermal Matrices

NCT02891759 | Completed Phase 2 DMC

• 1 other identifier: 201608168
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Patient satisfaction as measured by Breast Q

  Up to 15 months

• Health related quality of life as measured by Breast Q

  Up to 15 months

• Duration of drain use

  Up to 15 months

• Incidence of analgesic use for pain

  Up to 15 months

• Incidence of infection as measured by presence or absence of cellulitis

  Up to 15 months

Study Arms (2)

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

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

Other: Cortiva 1mm Allograft Dermis; Procedure: Skin or nipple-sparing mastectomy; Other: Breast Q; Procedure: Surgery

Interventions

Alloderm RTU OTHER

-Most commonly used acellular dermal matrices

Group A: Alloderm RTU

Cortiva 1mm Allograft Dermis OTHER

-Tutoplast processed dermis

Group B: Cortiva 1mm Allograft Dermis

Skin or nipple-sparing mastectomy PROCEDURE

-Standard of care

Group A: Alloderm RTU; Group B: Cortiva 1mm Allograft Dermis

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

Group A: Alloderm RTU; Group B: Cortiva 1mm Allograft Dermis

Surgery PROCEDURE

* To address the tissue expander * Standard of care

Group A: Alloderm RTU; Group B: Cortiva 1mm Allograft Dermis

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant and/or breastfeeding.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• RTI Surgical: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Subcutaneous; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mastectomy

Study Officials

• Terence M Myckatyn, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: January 31, 2017
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)