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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermacell | Active Comparator | Device for immediate implant based breast reconstruction |
|
| Alloderm | Active Comparator | Device for immediate implant based breast reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alloderm | Device | Reconstruction material |
| |
| Dermacell |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Duration of Drain Placements | Postoperative duration of drain placements for each postoperative breast. | within 6 months of initial surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angel Arnaout, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33704185 | Result | 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. |
| Label | URL |
|---|---|
| The Rethinking Clinical Trials (REaCT) website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dermacell | Device for immediate implant based breast reconstruction Dermacell: Reconstruction material |
| FG001 | Alloderm | Device for immediate implant based breast reconstruction Alloderm: Reconstruction material |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dermacell | Device for immediate implant based breast reconstruction Dermacell: Reconstruction material |
| BG001 | Alloderm | Device for immediate implant based breast reconstruction Alloderm: Reconstruction material |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Duration of Drain Placements | Postoperative duration of drain placements for each postoperative breast. | Participants may have had surgery on one or both breasts. | Posted | Mean | Standard Deviation | days | within 6 months of initial surgery | breasts | breasts |
|
All-Cause Mortality was collected within 6 months of surgery (baseline).
Serious adverse events and other adverse events collection/reporting were not reported. Adverse events were not included in the protocol as this was a pragmatic clinical trial comparing two standard of care interventions. Clinical complications were collected as secondary outcomes, which were collected by a variety study staff and not graded as adverse events (CTCAE).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dermacell | Device for immediate implant based breast reconstruction Dermacell: Reconstruction material |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jing Zhang | The Ottawa Hospital | 613-798-5555 | jzhang1@toh.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2016 | Mar 31, 2025 | Prot_SAP_000.pdf |
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| Device |
Reconstruction material |
|
| 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 | Wound dehiscence is a post-operative complication. Wound debridement is a procedure. This outcome was collected on a post-surgery case report form. | 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. | within 6 months of initial surgery |
| Number of Plastic Surgeon Visits | 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Female is an inclusion criteria. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal. | Number | participants |
|
| Smoking history | This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| breasts |
|
|
|
| Secondary | Number of Breasts With an Episode of Seroma Formation Requiring Aspiration | Posted | Count of Units | breasts | within 6 months of initial surgery | breasts | breasts |
|
|
|
| Secondary | Number of Breasts With Loss of Implant | Posted | Count of Units | breasts | within 6 months of initial surgery | breasts | breasts |
|
|
|
| Secondary | Number of Breasts With Events of Revisional Surgery/ Return to Operating Room | Posted | Count of Units | breasts | within 6 months of initial surgery | breasts | breasts |
|
|
|
| Secondary | 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. | Posted | Count of Units | breasts | within 6 months of initial surgery | breasts | breasts |
|
|
|
| Secondary | 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. | Posted | Count of Units | breasts | within 6 months of initial surgery | breasts | breasts |
|
|
|
| Secondary | Number of Plastic Surgeon Visits | The type of units is breasts. One participant could have had surgery on two breasts. | Posted | Median | Inter-Quartile Range | visits | within 6 months of initial surgery | Breasts | Breasts |
|
|
|
| Secondary | 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 | Data for this outcome was not collected due to funding limitations. Data will not be collected in the future. | Posted | 2 years |
|
|
| 1 |
| 31 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Alloderm | Device for immediate implant based breast reconstruction Alloderm: Reconstruction material | 0 | 31 | 0 | 0 | 0 | 0 |
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| Never |
|