The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction (REaCT-ADM)

A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.

Study Overview

• Status: Completed
• Conditions: Breast Reconstruction
• Intervention / Treatment: Device: Dermacell; Device: Alloderm

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H8L6
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patient
• Ages 20-90
• All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction
• Able to provide verbal consent

Exclusion Criteria:

• Patients who have had prior chest wall or irradiation on the reconstructed side
• Patients not undergoing immediate breast reconstruction at the time of mastectomy
• Any patient with a contraindication to immediate breast reconstruction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dermacell; Device for immediate implant based breast reconstruction	Device: Dermacell; Reconstruction material
Active Comparator: Alloderm; Device for immediate implant based breast reconstruction	Device: Alloderm; Reconstruction material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Duration of Drain Placements	Postoperative duration of drain placements for each postoperative breast.	within 6 months of initial surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Breasts With an Episode of Seroma Formation Requiring Aspiration		within 6 months of initial surgery
Number of Breasts With Loss of Implant		within 6 months of initial surgery
Number of Breasts With Events of Revisional Surgery/ Return to Operating Room		within 6 months of initial surgery
Number of Breasts With Wound Dehiscence or Debridement	Wound dehiscence is a post-operative complication. Wound debridement is a procedure. This outcome was collected on a post-surgery case report form.	within 6 months of initial surgery
Number of Breasts With Capsular Contracture (as Identified by the Plastic Surgeon)	Capsular contracture is a post-operative complication identified by the plastic surgeon. This outcome was collected on a post-surgery case report form.	within 6 months of initial surgery
Number of Plastic Surgeon Visits		within 6 months of initial surgery
Economics of Total Costs	Economic impact will be assessed based on calculation of total costs with each material used to include the material costs, duration of operative room use, clinic and inpatient hospital costs, surgical billing costs and anaesthesia costs	2 years

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Angel Arnaout, MD, The Ottawa Hospital

Publications and helpful links

General Publications

• Arnaout A, Zhang J, Frank S, Momtazi M, Cordeiro E, Roberts A, Ghumman A, Fergusson D, Stober C, Pond G, Jeong A, Vandermeer L, Hutton B, Clemons M, On Behalf Of The REaCT Investigators. A Randomized Controlled Trial Comparing Alloderm-RTU with DermACELL in Immediate Subpectoral Implant-Based Breast Reconstruction. Curr Oncol. 2020 Dec 25;28(1):184-195. doi: 10.3390/curroncol28010020.

Helpful Links

• The Rethinking Clinical Trials (REaCT) website

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): October 11, 2018
• Study Completion (Actual): February 19, 2019

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: acellular dermal matrix; breast reconstruction; mastectomy
• Other Study ID Numbers: OTT 16-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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