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higher rate of post-operative infection in the Dermal Matrix arm of the study
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We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DermaMatrix | Experimental | experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications |
|
| Standard of care | Active Comparator | standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DermaMatrix | Procedure | experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction With the Procedure | one year from time of operation | |
| Post Surgical Infection | Number of participants with post surgical infection | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Wendel, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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recruited from the clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | DermaMatrix | experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications |
| FG001 | Standard of Care | standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Available data lists demographic data as a single group. Breakdown by arms is not available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Both Arms |
| 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 |
| 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 | Patient Satisfaction With the Procedure | study was terminated and 1 year follow up was not done | Posted | one year from time of operation |
|
1 year
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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 | DermaMatrix | experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Surgical and medical procedures | Systematic Assessment |
Unable to contact PI after he left Vanderbilt. Results were entered with available data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Wendel, MD | Vanderbilt University Medical Center | 615-936-0160 | jason.wendel@vanderbilt.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| standard of care tissue expander breast reconstruction surgery after mastectomy | Procedure | standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Post Surgical Infection | Number of participants with post surgical infection | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 6 |
| 20 |
| EG001 | Standard of Care | standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix | 0 | 16 | 0 | 16 | 2 | 16 |
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| D017437 |
| Skin and Connective Tissue Diseases |