Breast Reconstruction
Conditions
Keywords
acellular dermal matrix, mastectomy, breast reconstruction
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.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Duration of Drain Placements | within 6 months of initial surgery | Postoperative duration of drain placements for each postoperative breast. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Wound dehiscence is a post-operative complication. Wound debridement is a procedure. This outcome was collected on a post-surgery case report form. |
| Number of Breasts With Capsular Contracture (as Identified by the Plastic Surgeon) | within 6 months of initial surgery | Capsular contracture is a post-operative complication identified by the plastic surgeon. This outcome was collected on a post-surgery case report form. |
| Number of Plastic Surgeon Visits | within 6 months of initial surgery | — |
| Economics of Total Costs | 2 years | 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORAngel Arnaout, MD
The Ottawa Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 11.1 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Canada | 31 participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 0 Participants |
| Smoking history Current | 4 Participants |
| Smoking history Never | 19 Participants |
| Smoking history Prior (>1 or equal to month before) | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed