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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Device: Alloderm
* Device: Dermacell


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dermacell<br>Device for immediate implant based breast reconstruction | Device: Dermacell<br>* Reconstruction material<br>|
| Active Comparator: Alloderm<br>Device for immediate implant based breast reconstruction | Device: Alloderm<br>* Reconstruction material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative duration of drain placements |  | within 6 months of initial surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of seroma formation requiring aspiration |  | within 6 months of initial surgery | 
| Loss of implant |  | within 6 months of initial surgery | 
| Revisional surgery/ return to operating room |  | within 6 months of initial surgery | 
| Wound dehiscence or debridement |  | within 6 months of initial surgery | 
| Capsular contracture (as identified by the plastic surgeon) |  | within 6 months of initial surgery | 
| Number of additional postoperative clinic visits with the plastic surgeon (beyond the routine) |  | 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 |