A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Phase: NA
Conditions: Breast Reconstruction
Sponsor: Ottawa Hospital Research Institute

November 24, 2016 
A randomised controlled trial comparing the use of Alloderm versus Dermacell in immediate 
implant based breast reconstruction (REaCT-ADM) 
Coordinating Centre: 
Principal Investigator: 
Co-Principal Investigators: 
The Ottawa Hospital Cancer Centre 
Angel Arnaout, MD 
The Ottawa Hospital Cancer Centre 
E-mail: anarnaout@toh.ca
Drs. E. Cordeiro (Breast Surgeon), J Zhang (Plastic 
Surgeon), A. Ghumman (Plastic Surgeon) 
Funding provided by: Ottawa REaCT Program 
Protocol Type: Version November 24, 2016 

November 24, 2016 
Protocol Version:  November 24, 2016 
 
PROTOCOL SIGNATURE PAGE 
 
My signature below confirms that I have reviewed and approved this protocol, and 
agree that it contains all necessary details for carrying out the study as described. I will 
conduct this protocol as outlined therein, and according to Good Clinical Practice and all 
applicable local regulations 
 
 
 
 
 
 
 
 
 
 
 
Qualified Investigator (Please Print) 
 
 
 
 
 
 
 
 
 
 
 
Qualified Investigator Signature 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 

November 24, 2016 
1. Background:  
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 [1]. In general, 
breast reconstruction can be accomplished using the patient’s own tissues (autologous), or 
implantable prosthetic devices (alloplastic reconstruction or breast implants). Over the last 
decade, there has been a significant increase in the rate of alloplastic reconstructions compared 
with autologous tissue reconstructions in North America [1-3].  
Acellular dermal matrix (ADM) has been increasingly used in alloplastic reconstruction. ADMs 
are biological materials, typically of human, bovine, or porcine origin [3-6]. The tissue is 
processed to remove cells as well as any antigenic component to prevent immune reaction, 
resulting in a residual collagen matrix or scaffold that facilitates tissue ingrowth and 
revascularization by the host following implantation. Originally described for the use in 
resurfacing of burn injuries and abdominal wall repair; ADMs are now commonly used in the 
field of implant-based breast reconstruction post mastectomy (Figure 1). The advantages of 
ADM-assisted implant reconstruction is that it provides additional tissue coverage and helps in 
the positioning of the implant while minimizing peri-prosthetic fibrosis (i.e. capsular contracture) 
[6-8], the latter being especially important for patients who receive adjuvant radiation as part of 
their breast cancer treatment [9]. Whereas traditional implant-based breast reconstruction occurs 
in a “delayed” fashion, performed at least 6 months post mastectomy; the use of ADMs have 
allowed conversion in the appropriate patient to a single stage, “immediate” breast reconstruction 
(done at the same operative procedure as the mastectomy) [3-6].  
 

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The significant impact on reduced operative procedures for the patient [6-9], psychological 
benefit from having restoration of the breast immediately post mastectomy (i.e. direct to implant 
breast reconstruction) [10-11], cost savings from sparing a second surgery [12-15] as well as 
improved aesthetic outcomes (compared to non-ADM assisted breast implant reconstruction) 
[16-17] has made the ADM-assisted approach to become a standard of care at many centers and 
widely adopted throughout the world [18-21]. Currently at the Ottawa Hospital, a cursory audit 
in 2015 demonstrated that approximately 50% of the 800 breast cancer patients underwent a 
mastectomy; 25% of these underwent immediate breast reconstruction for which ADM is used 
(i.e. around 100 breast cases per year).  
Patients who undergo direct-to-implant breast reconstruction with ADMs have been found to 
experience similar rates of postoperative complications compared with patients who undergo 
two-stage reconstruction without ADMs, and therefore this procedure is generally considered to 
be a safe and reliable approach to breast reconstruction [18-23]. A summary of the evidence on 
outcomes after direct-to-implant breast reconstruction using ADMs is presented in Table 1. 
Overall, direct-to-implant reconstruction outcomes compare favourably with the Mentor and 
Allergan Core Study results, which tracked complications and revision rates following delayed 
two-stage implant reconstruction without ADM (24,25). On short-term follow-up, weighted 
analysis of the studies in Table 1 shows direct-to-implant reconstruction with ADM to have 
lower rates of capsular contracture comapred to two-stage reconstruction without ADM (0.3% 
versus 8.3% to 17.1%), seroma (1.2% versus 4.9%), infection (1.4% versus 3.2% to 5.7%), late 
revision (8.5% versus 27% to 53.3%) and implant loss (1.5% versus 5.7% to 7.7%). Higher rates 
of mastectomy flap necrosis in immediate reconstruction with ADM (4.7% versus 2.3%) may be 

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related to increased tension placed on the skin closure with immediate placement of the 
permanent prosthesis.  
 
Various 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 [2-4,32]. The difference between the two products include a) the 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 difference in cost (standard 6x16cm piece 
of Dermacell = $2200 CAD and Alloderm = $3600 CAD). For a typical patient, the difference in 
cost for the hospital is about $1400. Supporters of Dermacell advocate for its lower cost and 
increased sterility; whether the difference in sterility translates into a clinical difference in 
infection rate is unclear (standard procedure is to sterilize to 10-6 for operative devices) [32-36]. 
Supporters of Alloderm advocate based on its longer term data on safety and effectiveness (2-
4,19,32] as it is the ADM that has been around the longest. Each product has shown to be safe 
and effective (32-26). As such there exists clinical equipoise. Currently, the selection of ADM is 
based on non-clinical idiosyncratic decision making factors, such as the hospital’s previous 
relationship with the vendors and preference of the surgeon. Both products are equally available 
to Canadian hospitals and currently at the Ottawa Hospital the product used is dependent on 
surgeon preference.  
 
1.1 The REaCT Program 
New cancer treatments are developed through occurrence of randomized clinical trials (RCTs), 
comparing with either a placebo or an established treatment. Pharmaceutical company funded 

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trials establish the new treatments as being; better, worse or more commonly equivalent to 
established therapies. As a result, in clinical practice, physicians may be faced with multiple 
funded “standards of care”. However, comparative standard of care treatment trials are rarely 
conducted. One of the major barriers is expense. It is incredibly expensive to perform clinical 
trials as their regulatory oversight (patient consent, REB submission, contracts, drug costs, 
research coordination and management, data collection of multiple often superfluous endpoints, 
analysis) has been designed around trials of new agents or established agents for new indications. 
As physicians do not know what the “best” treatment for patients is, genuine uncertainty 
(“clinical equipoise”) exists. In the light of different strategies chosen by investigators between 
those two trials aforementioned, physicians will choose between different “standards” in their 
personal practice, using idiosyncratic decision making processes, without the physician or the 
patient knowing the optimal option. Determining the optimal treatment remains an important 
medical issue for both patients and physicians. 
This study will use an established methodology to allow comparisons of established 
standard of care treatment using the “integrated consent model” as part of a pragmatic clinical 
trial. By integrating medical and clinical practices, physicians will be able to inform their 
patients about the RCT, through a typical conversation between the physician and patient, 
without written informed consent. This clinical interaction would then be documented, as 
ordinarily done in practice.  
Pragmatic clinical trials are being given increased importance, as they commonly consist 
of comparative effectiveness research, thus comparing the safety and effectiveness of diagnostic, 
therapeutic or delivery systems. Additionally,  these studies have not only the ability to leverage 
patient data from electronic health records to increase sample size of trials at much lower costs, 

November 24, 2016 
but also enabling major national and international initiatives to generate the data needed to 
improve care. As such, the Integrated Consent Model is being increasingly used internationally 
to improve patient care. In fact, the Ottawa Hospital Cancer Centre is leading this program with 
over 150 patients already enrolled on REACT trials at four Canadian Cancer Centres (Ottawa, 
Kingston, Edmonton, Kitchener). These studies have shown excellent patient feedback with 97% 
of patients rating being ‘completely satisfied’ with the REACT process.  
 
Thus, we propose a pragmatic clinical trial to evaluate Alloderm with Dermacell in a head to 
head randomized fashion, with regards to the postoperative complications, namely infection, 
seroma formation (as measure by drain duration and output), loss of the implant, incidence of 
revisional surgery and capsular contracture. These postoperative sequelae have significant 
implications to the patient, surgeon and health care system.  The most significant of these are 
postoperative infection, which can result in prolonged antibiotic use, hospital admission, loss of 
implant, and delay in adjuvant breast cancer therapy. 
 
2.  Study Aim 
The aim of this study is to evaluate the postsurgical complications of Alloderm versus Dermacell 
use in immediate breast reconstruction. 

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3. Hypothesis 
We predict that Dermacell will have reduced postoperative comlications as compared to 
Alloderm due to its improved sterility. 
4. Consent Process 
Patients will be asked to provide oral consent to be randomized to once either Alloderm or 
Dermacell. In this study the investigator will obtain oral consent using the attached REB 
approved consent script. 
 
If the patient agrees to participate in the study, then the surgeon will dictate in the progress note 
they have had the above type of conversation with the patient. There will be no need for the 
patient to sign an informed consent form. The patient will be given a written summary of the 
general information about the study as well.  
 
4.  Study Design 
In this randomized superiority trial, the site investigator will have the on-line program uploaded 
to their health authority secured computer in clinic or electronic portable device (e.g. 
smartphone) in order to randomize participants. The surgeon must dictate that the verbal consent 
and eligibility review has taken place prior to randomization.  
 
Inclusion Criteria:  
 Female patient 
 Ages 20-90 

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 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 
It should be noted that patients who undergo bilateral mastectomy and bilateral immediate 
implant reconstruction should be randomized to the same type of ADM for each breast ie the 
randomization is at the patient level and not the breast level. Patients having bilateral 
mastectomy will have each breast evaluated separately, as 2 entries the final results database. 
Both breasts of the same patient will receive the same randomization arm.  
A history of smoking, BMI > 40, and D cup breast size or grade III ptosis are all 
contraindications to immediate breast reconstruction as the risk of postoperative complications 
are significantly higher (wound infection, dehiscence, implant loss, seroma) than the average 
patient and thus these patients would be excluded from the study. 
 
5. Outcomes 
Primary outcome: Postoperative duration of drain placement (days) 
Secondary outcomes: All outcomes are measured within 6 months of the initial surgery 
 Episodes of seroma formation requiring aspiration 

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 Loss of implant  
 Revisional surgery/ return to operating room 
 Wound dehiscence or debridement  
 Capsular contracture (as identified by the plastic surgeon)  
 Number of additional postoperative clinic visits with the plastic surgeon (beyond the routine)  
 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  
 
6. Study Procedures 
All patients undergoing mastectomy for breast cancer or breast cancer prophylaxis are seen at the 
WBHC at the Ottawa Hospital. Patients eligible and consenting for for immediate breast 
reconstruction with an implant will be introduced to the REACT-ADM study and a standardized 
verbal consent for randomization will be recorded in the clinic notes. The clinical research 
assistant (CRA) will be performing the randomization and will inform the surgeon on the day of 
surgery with regards to the randomization arm immediately before the surgery.  Both Dermacell 
and Alloderm will be readily available in the operating room for use in case of randomization 
into either arm. 
The plastic surgeon will be informed of the randomization arm and will proceed with the surgery 
in the usual fashion, with standard, equivalent procedures used for both (aseptic technique, 
drainsplacement, oral antibiotics for  1 week postoperatively). The routine schedule of 
postoperative follow-up of these patients is as follows: 

November 24, 2016 
 
Breast Surgeon: 
 2 weeks 
 6 months 
 
Plastic Surgeon:  
 1 weeks 
 2 weeks 
 6 months 
 
 
7.  Sample size calculation and Data Analysis Plan  
The primary endpoint of the study is drain duration (days). Mean postoperative duration of drain 
placement is 10 days. As per informal discussion with the plastic and breast surgeons, a 
minimum of 4 days in drain duration between the 2 arms will be considered clinically significant. 
We are hypothesizing that there will be minimum of 4 day difference in drain duration, in favour 
of Dermacell as this is a superiority trial. As such, we will require 50 patients total (25 per arm) 
to demonstrate a 4 day difference in drainage duration (14 vs 10) with a standard deviation of 5. 
Allowing for a 105 study drop out rate, we will require a total of 56 pts or 23 patients per arm. 
The Ottawa Hospital currently performs 100 immediate breast reconstructions per year with 
ADM. As such, the study duration would be expected to be 1 years. Data will be analysed at the 
end of the year.  

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The primary endpoint of the study is drain duration (days). We will compare mean  postoperative 
duration of drain placement between both arms by calculating the post-randomization absolute 
mean difference in durations and its 95% confidence interval. We will also present the associated 
two-sample t-statistic. If data are not normally distributed, we will compare groups using a 
Mann-Whitney test. Our dichotomous secondary outcomes (episodes of seroma formation 
requiring aspiration, loss of implant, revisional surgery/ return to operating room, wound 
dehiscence or debridement, capsular contracture (as identified by the plastic surgeon) will be 
analyzed be calculating relative risk ratios and their 95% confidence intervals. Our continuous 
outcome (number of additional postoperative clinic visits with the plastic surgeon beyond the 
routine) will be analyzed using parametric (t-statistic) or non-parametric (Mann-Whitney) tests 
depending on distribution of occurrences.  Patients having bilateral mastectomy will have each 
breast evaluated separately, as 2 entries the final results database. Both breasts of the same 
patient will receive the same randomization arm.  
 
8. Data Collection 
Once the patient has been randomized, the study CRA will collect participant information via 
electronic health records. From a study standpoint only the CRA will access this information. 
Data not available at the time of visit will be collected from the dictated physician/surgeon note. 
At the time of randomization the software will also generate a reminder email to the patient’s 
physician to collect study related data.  Patients having bilateral mastectomy will have each  
breast evaluated separately, as 2 entries the final results database. However, both breasts of the 
same patient will receive the same randomization arm. 
9. Risks 

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There are no incremental risks associated with this study as both arms are standard of care 
treatments. 
10. Premature withdrawl  
Participants have the right to withdraw from the study treatment at any time for any reason. 
Investigator has the right and obligation to withdraw subjects from the study treatment in the 
event of: 
 Intercurrent illnesses which would, in the judgment of the investigator, affect assessment 
of clinical status to a significant degree, and require discontinuation of protocol therapy 
 Any toxicity that would produce further harm if continued on the protocol 
 Request by the participant  or  of their legally authorized representative (consent 
withdrawal) 
 Non-compliance to the study protocol or logistic consideration 
 Participant  is lost to follow-up 
 
11.Monitoring 
This study will be conducted according to the International Conference on Harmonisation Good 
Clinical Practice Guidelines.  Routine quality assurance will be completed by the Ottawa 
Hospital Research Institute and its delegates to ensure that the study is being run according to the 
protocol at the participating site. This monitoring will include: 
- 
random spot checks on inclusion and exclusion criteria to confirm that only eligible 
patients are participating in the trial 
- 
routine evaluation of source data to ensure accuracy 
- 
evaluation of the first set of case report forms from each site to ensure that they are being 
completed according to the protocol. 
 

November 24, 2016 
 
 
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Figure 1: Illustration of role of acellular dermal matrix in implant based reconstruction. 
 
 
 
 
 
 
 

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Note: weighted averages calculated by breast. 
*LifeCell Corporation, USA; 
†Studies with a mix of one- and two-stage reconstructions, or studies that did not report results by breast not included in weighted 
average; 
‡Allergan Inc, USA;   §Mentor Worldwide LLC, USA. N/D Not documented