NCT03064893

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2019

Completed
7 years until next milestone

Results Posted

Study results publicly available

January 30, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

December 14, 2016

Results QC Date

April 1, 2025

Last Update Submit

January 13, 2026

Conditions

Breast Reconstruction

Keywords

acellular dermal matrixmastectomybreast reconstruction

Outcome Measures

Primary Outcomes (1)

  • Postoperative Duration of Drain Placements

    Postoperative duration of drain placements for each postoperative breast.

    within 6 months of initial surgery

Secondary Outcomes (7)

  • 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

    within 6 months of initial surgery

  • Number of Breasts With Capsular Contracture (as Identified by the Plastic Surgeon)

    within 6 months of initial surgery

  • +2 more secondary outcomes

Study Arms (2)

Dermacell

ACTIVE COMPARATOR

Device for immediate implant based breast reconstruction

Device: Dermacell

Alloderm

ACTIVE COMPARATOR

Device for immediate implant based breast reconstruction

Device: Alloderm

Interventions

AllodermDEVICE

Reconstruction material

Alloderm
DermacellDEVICE

Reconstruction material

Dermacell

Eligibility Criteria

Age20 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 33704185RESULT

Related Links

Results Point of Contact

Title
Dr. Jing Zhang
Organization
The Ottawa Hospital
jzhang1@toh.ca
613-798-5555

Study Officials

  • Angel Arnaout, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2016

First Posted

February 27, 2017

Study Start

February 6, 2017

Primary Completion

October 11, 2018

Study Completion

February 19, 2019

Last Updated

January 30, 2026

Results First Posted

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)