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.
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.
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.
- Conditions
- Breast Reconstruction
- 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 group | Role | What they receive |
|---|---|---|
| Dermacell | Active comparator | Device for immediate implant based breast reconstruction Receives: Device: Dermacell |
| Alloderm | Active comparator | Device 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.
Postoperative Duration of Drain Placements
Postoperative duration of drain placements for each postoperative breast.
Measured: within 6 months of initial surgery
Secondary outcomes (7)
Number of Breasts With an Episode of Seroma Formation Requiring Aspiration
Measured: within 6 months of initial surgery
Number of Breasts With Loss of Implant
Measured: within 6 months of initial surgery
Number of Breasts With Events of Revisional Surgery/ Return to Operating Room
Measured: 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.
Measured: 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.
Measured: within 6 months of initial surgery
Number of Plastic Surgeon Visits
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start6 Feb 2017
- Primary completion11 Oct 2018
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angel Arnaout, MD, Principal investigator, The Ottawa Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03064893
- Acronym / sponsor ID
- REaCT-ADM / OTT 16-06
- Conditions
- Breast Reconstruction
- Keywords
- acellular dermal matrix, mastectomy, breast reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Posted 30 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermacell | Active comparator | Device: DermacellDevice for immediate implant based breast reconstruction |
| Alloderm | Active comparator | Device: AllodermDevice for immediate implant based breast reconstruction |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllodermReconstruction material | Device | Alloderm |
| DermacellReconstruction material | Device | Dermacell |
Primary outcome
Postoperative Duration of Drain Placements
Time frame: within 6 months of initial surgery
Postoperative duration of drain placements for each postoperative breast.
7 secondary outcomes
Number of Breasts With an Episode of Seroma Formation Requiring Aspiration
Time frame: within 6 months of initial surgery
Number of Breasts With Loss of Implant
Time frame: within 6 months of initial surgery
Number of Breasts With Events of Revisional Surgery/ Return to Operating Room
Time frame: within 6 months of initial surgery
Number of Breasts With Wound Dehiscence or Debridement
Time frame: within 6 months of initial surgery
Number of Breasts With Capsular Contracture (as Identified by the Plastic Surgeon)
Time frame: within 6 months of initial surgery
Number of Plastic Surgeon Visits
Time frame: within 6 months of initial surgery
Economics of Total Costs
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33704185Arnaout 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.
- The Rethinking Clinical Trials (REaCT) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Reconstruction
Recruiting
ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
Breast Cancer, Cancer of the Breast
RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Active, not recruiting
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Breast Reconstruction, Revision Breast Reconstruction
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Arnaout, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.