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Breast ReconstructionREaCT-ADMNCT03064893

The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

A study testing Alloderm and Dermacell in people with Breast Reconstruction, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 90 years, women only
Conditions the study is for
Breast Reconstruction
What is being tested?
Alloderm and Dermacell
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteCanada
Study dates
6 Feb 2017to 19 Feb 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6

Other trials in Canada

About this study

Official title: 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.

Being tested
Alloderm, Dermacell
Keywords
acellular dermal matrix, mastectomy, breast reconstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AllodermDevice

    Reconstruction material

  • DermacellDevice

    Reconstruction material

Study groups in NCT03064893
Study groupRoleWhat they receive
DermacellActive comparatorDevice for immediate implant based breast reconstruction
Receives: Device: Dermacell
AllodermActive comparatorDevice for immediate implant based breast reconstruction
Receives: Device: Alloderm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Duration of Drain Placements

    Postoperative duration of drain placements for each postoperative breast.

    Measured: within 6 months of initial surgery

Secondary outcomes (7)

  1. Number of Breasts With an Episode of Seroma Formation Requiring Aspiration

    Measured: within 6 months of initial surgery

  2. Number of Breasts With Loss of Implant

    Measured: within 6 months of initial surgery

  3. Number of Breasts With Events of Revisional Surgery/ Return to Operating Room

    Measured: within 6 months of initial surgery

  4. 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.

    Measured: within 6 months of initial surgery

  5. 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.

    Measured: within 6 months of initial surgery

  6. Number of Plastic Surgeon Visits

    Measured: within 6 months of initial surgery

  7. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2017
  2. Study start6 Feb 2017
  3. Primary completion11 Oct 2018
  4. Study completion19 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03064893
Sponsor's protocol ID
OTT 16-06
Acronym
REaCT-ADM
Status last verified
Jan 2026
First submitted
14 Dec 2016
Last updated
30 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33704185

Questions about this trial

What is this clinical trial studying?

A study testing Alloderm and Dermacell in people with Breast Reconstruction, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Duration of Drain Placements (time frame: within 6 months of initial surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03064893, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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