BREAST ADM Trial for Alloplastic Breast Reconstruction (Breast_ADM)

The BREAST Trial: A Randomized, Non-inferiority, Study Comparing the Complication Profile of Four Commercially Available Acellular Dermal Matrixes Used in Alloplastic Breast Reconstruction

This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.

Study Overview

• Status: Recruiting
• Conditions: Breast Reconstruction
• Intervention / Treatment: Device: AlloDerm; Device: AlloMax; Device: DermACELL; Device: Flex HD

Detailed Description

This study is a randomized control trial and will include all patients who are agreeable and deemed appropriate for alloplastic breast reconstruction involving the use of an ADM with two stage tissue expander (TE) reconstruction. The ADMs used will be determined by random assignment to one of four available products being utilized within the study: AlloDerm, AlloMax, DermACELL and FlexHD. Each ADM product will comprise of an individual treatment arm. Participants undergoing bilateral reconstruction will have the same ADM used in each side. The four treatment arms will be compared to assess their impact on our primary outcome: proportion of clinically significant post-operative seroma requiring intervention. Analysis will be performed per surgeon to prevent post-operative outcomes from being confounded by the principle operator. The trial will initially be conducted as an internal pilot study. The study will initially target a study population of 40 patients for recruitment as a means to assess the feasibility of the study. In doing this, the pilot study will be able to establish the necessary protocol and administrative infrastructure that is needed to complete the trial in its entirety. This create a sample population for initial outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 328
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Nancy Van Laeken; Phone Number: 604-669-1633; Email: nancy@vanlaeken.com
• Study Contact Backup: Name: Raveena Gowda; Email: raveena.gowda@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • Vancouver General Hospital
      • Contact: Dr. Peter Lennox, MD, FRCSC; Phone Number: 604-876-6552; Email: peter.lennox@ubc.ca
    • Vancouver, British Columbia, Canada, V5T 3N4
      • Recruiting
      • Mount Saint Joseph's Hospital
      • Contact: Dr. Nancy Van Laeken, MD, FRCSC; Phone Number: 5 604-669-1633; Email: Nancy@vanlaeken.com
    • Vancouver, British Columbia, Canada, V6T 1Z7
      • Recruiting
      • UBC Hospital
      • Contact: Dr. Sheina Macadam, MD, FRCSC; Phone Number: 604-876-1688; Email: drsmacadam@drsheinamacadam.com
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • Saint Paul's Hospital
      • Contact: Dr. Kathryn Isaac, MD, FRCSC; Phone Number: 604-336-8488; Email: kathryn.isaac@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM.
• Breast reconstruction must be done by means of a two staged process using tissue expanders and ADM based reconstruction followed by implant tissue expander to implant exchange.

Exclusion Criteria:

• Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion.
• Patients with a history of previous breast reconstruction procedures.
• Patients with prior radiation treatment to the breast or with prior mantle radiation
• Any patient with a contraindication to breast reconstruction
• Patients undergoing an axillary node dissection with clearance
• Patients with an allergy to Polysporin or any of its ingredients.

• Patients with contraindications to any of the acellular dermal matrices:

  • DermACELL: Allergy to Gentamicin, Vancomycin[12]

• The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively, there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AlloDerm group; Device for immediate implant based breast reconstruction.	Device: AlloDerm; Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
Active Comparator: AlloMax group; Device for immediate implant based breast reconstruction.	Device: AlloMax; Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
Active Comparator: DermACELL group; Device for immediate implant based breast reconstruction.	Device: DermACELL; Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
Active Comparator: Flex HD group; Device for immediate implant based breast reconstruction.	Device: Flex HD; Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma incidence	Incidence of seroma formation requiring intervention including aspiration in-office or ultrasound-guided drainage	Within 6 months of stage I or stage II surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean drain duration (Days)	Postoperative duration of drain placements	Within 1 month of stage I or stage II surgery
Mean drain output (ml)	Total volume of drain output until drain removal	Within 1 month of stage I or stage II surgery
Mean seroma volume (ml)	Total volume of seroma fluid aspirated until resolution of seroma	Within 6 months of stage I or stage II surgery
Mean aspirations per seroma	Number of aspirations required for seroma resolution	Within 6 months of stage I or stage II surgery
Hematoma incidence	Incidence of hematoma requiring evacuation or aspiration	Within 1 month of stage I or stage II surgery
Surgical site infection incidence	Incidence of surgical site infection requiring antibiotics or operative management	Within 6 months of stage I or stage II surgery
Number of Participants with Implant loss	Loss of Implant for any reason (wound dehiscence, exposure, periprosthetic infection)	Within 2 year of stage II surgery
Number of Participants with Red breast syndrome	Noninfectious erythema localized to the area of ADM reconstruction	Within 1 month of stage I surgery
Number of Participants with Unplanned surgical care	Unexpected return to the operating room that was not planned at the initial visit for any reason	Within 2 year of stage I or stage II surgery
Number of Participants with Mastectomy flap necrosis	Mastectomy flap necrosis and associated management: expectant, office debridement, or return to the operating room	Within 1 month of stage I surgery
Capsular contracture incidence	Incidence of capsular contracture (as identified by the plastic surgeon, grouped by Baker's classification of severity)	Within 1 year of stage II surgery
ADM integration assessment	Clinical assessment of ADM integration into the breast pocket at the time of the second stage procedure.	Within 1 month of stage II procedure
Post-operative aesthetic assessment (patient and surgeon)	Subjective assessment of cosmetic outcome by the patient and blinded assessors using post-operative aesthetic breast survey assessment	Within 2 years of stage II surgery
Pre and post-operative satisfaction assessed using BREAST-Q	Evaluation of the satisfaction and quality of life of patients undergoing breast surgery using the BREAST-Q. Breast-Q is based on Breast Cancer Core Scale ranging from 0 to 100. Higher score means better outcome.	Within 2 years of stage II surgery

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Dr. Nancy Van Laeken, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H18-02052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No