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| Name | Class |
|---|---|
| Women's College Hospital | OTHER |
| Vancouver General Hospital | OTHER |
| Canadian Breast Cancer Foundation | OTHER |
| Tom Baker Cancer Centre |
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Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy. This procedure has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. The primary drawback, however, is that it requires two separate procedures under general anesthesia and multiple office visits for expander inflation to create the breast mound. Acellular dermal matrix has gained widespread acceptance for use in breast reconstruction and other areas and has the potential to provide support to the breast implant without tissue expansion in a one-stage procedure. The purpose of the study is to test this new procedure and to evaluate the impact of one-stage breast reconstruction using acellular dermis compared to the standard two-stage expander/implant technique on measures of patient satisfaction and quality of life.
Recently, there has been significant focus on the performance of skin-sparing mastectomies in certain types of breast cancer patients. These treatments may be performed for prophylactic mastectomy but also have been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. Currently, the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy, however there are significant disadvantages as this technique requires two separate surgeries and multiple office visits to complete that may affect a patients quality of life. Medically safe compounds such as acellular dermal matrix have been developed that have the potential to support breast implants without requiring numerous tissue expansions and consequently providing the potential for a one-stage breast implant/reconstruction procedure for immediate, skin-sparing mastectomies.
To examine patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-staged breast reconstruction at 2 weeks, 6 & 12 months following completion of the reconstruction. Hypothesis 2: Patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-stage breast reconstruction is superior to that following the standard two-stage tissue expander/ implant breast reconstruction technique in selected mastectomy patients.
To determine the short and long-term operative complication rates associated with the use of dermal matrix in one-stage immediate breast reconstruction following skin-sparing mastectomy. Hypothesis 1: The use of acellular dermal matrix in one-stage immediate prosthetic breast reconstruction is associated with decreased short and long-term postoperative complications compared with the traditional two staged tissue expander/implant procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-stage dermal matrix/implant | Experimental | One-stage breast reconstruction with dermal matrix and implant |
|
| Two-stage tissue expander/implant | Active Comparator | Two-stage breast reconstruction with tissue expander and implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-stage dermal matrix/implant procedure | Procedure | One-stage breast reconstruction with dermal matrix and implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| BreastQ Quality of Life and Satisfaction Questionnaire | Compare the change in the patient satisfaction and QOL scores between one-stage ADM-assisted and two-stage TE/I reconstruction without ADM over time (at 2 weeks after mastectomy, at 6 months and at 12 months following the final reconstruction procedure) from baseline scores following reconstruction using the validated BREAST-Q reconstruction module. The BREAST-Q Reconstruction Module is used to measure outcomes across four domains/sub-scales: satisfaction with the breast, psychosocial wellbeing, physical wellbeing, and sexual wellbeing. Each domain is scored on a scale of 1 to 100, with higher scores indicating better quality of life and greater patient satisfaction with more favorable outcomes. | 12 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Short Term Surgical Complications | Short complication rates were collected prospectively on intraoperative and postoperative assessment forms. Short-term complications were those that occur intraoperatively or within the first 2 months of surgery | 6- months post-op |
| Number of Participants With Long Term Surgical Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toni Zhong, MD FRCS(C) | University Health Network, Toronto | Principal Investigator |
| Mitchell Brown, MD FRCS(C) | Women's College Hospital | Principal Investigator |
| Stefan Hofer, MD FRCS(C) | University Health Network, Toronto | Principal Investigator |
| John Semple, MD FRCS(C) | Women's College Hospital | Principal Investigator |
| Brett Beber, MD FRCS(C) | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada | ||
| Vancouver General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24165392 | Derived | Zhong T, Temple-Oberle C, Hofer SO, Beber B, Semple J, Brown M, Macadam S, Lennox P, Panzarella T, McCarthy C, Baxter N; MCCAT Study Group. The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction. Trials. 2013 Oct 28;14:356. doi: 10.1186/1745-6215-14-356. |
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| ID | Title | Description |
|---|---|---|
| FG000 | One-stage Dermal Matrix/Implant | One-stage breast reconstruction with dermal matrix and implant One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant |
| FG001 | Two-stage Tissue Expander/Implant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jun 15, 2011 |
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| OTHER |
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| Two-stage tissue expander/implant procedure | Procedure | Two-stage breast reconstruction with tissue expander and implant |
|
Long-term minor and major surgical complication rates were documented and collected prospectively on intraoperative and postoperative assessment form at 12-months follow-up visit |
| 12 months post-op |
| Vancouver |
| British Columbia |
| V5Z 1M9 |
| Canada |
| Plastic Surgery, Women's College Hospital | Toronto | Ontario | M5G 1N8 | Canada |
| Plastic and Reconstructive Surgery, University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
Two-stage breast reconstruction with tissue expander and implant Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One-stage Dermal Matrix/Implant | One-stage breast reconstruction with dermal matrix and implant One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant |
| BG001 | Two-stage Tissue Expander/Implant | Two-stage breast reconstruction with tissue expander and implant Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | BreastQ Quality of Life and Satisfaction Questionnaire | Compare the change in the patient satisfaction and QOL scores between one-stage ADM-assisted and two-stage TE/I reconstruction without ADM over time (at 2 weeks after mastectomy, at 6 months and at 12 months following the final reconstruction procedure) from baseline scores following reconstruction using the validated BREAST-Q reconstruction module. The BREAST-Q Reconstruction Module is used to measure outcomes across four domains/sub-scales: satisfaction with the breast, psychosocial wellbeing, physical wellbeing, and sexual wellbeing. Each domain is scored on a scale of 1 to 100, with higher scores indicating better quality of life and greater patient satisfaction with more favorable outcomes. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-op |
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| Secondary | Number of Participants With Short Term Surgical Complications | Short complication rates were collected prospectively on intraoperative and postoperative assessment forms. Short-term complications were those that occur intraoperatively or within the first 2 months of surgery | Posted | Count of Participants | Participants | 6- months post-op |
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| Secondary | Number of Participants With Long Term Surgical Complications | Long-term minor and major surgical complication rates were documented and collected prospectively on intraoperative and postoperative assessment form at 12-months follow-up visit | Posted | Count of Participants | Participants | 12 months post-op |
|
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2 years
Chart reviewed on a regular schedule.
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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 | One-stage Dermal Matrix/Implant | One-stage breast reconstruction with dermal matrix and implant One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant | 0 | 86 | 0 | 86 | 7 | 86 |
| EG001 | Two-stage Tissue Expander/Implant | Two-stage breast reconstruction with tissue expander and implant Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant | 0 | 78 | 0 | 78 | 6 | 78 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant or TE exposure | Surgical and medical procedures | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Toni Zhong | University Health Network | 4163404800 | 2343 | kbutler@uhnresearch.ca |
| Sep 28, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| C440568 | Alloderm |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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A minimally clinically important difference of 4 as statistically significant at the 0.05 level (two-sided), with a power equal to 0.85. |
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