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Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed.
The goal of this study is to compare a traditional single port expander with a two-port expander for equivalency when used for breast reconstruction following mastectomy. Complication rates that will be tracked include seroma, mastectomy skin flap necrosis, infection, wound dehiscence, need for explantation of the expander. Management of seromas will be compared between the two groups. The investigators hypothesize that the AlloX2 expander will be as effective in achieving the final outcome of completion of the second stage of reconstruction with equal or improved complication rates.
Study Design A prospective 1:1 randomized, single center, open label study will compare the traditional 1- port tissue expander with the AlloX2 2-port expander placed during immediate tissue expander breast reconstruction. Due to the nature of the surgery, the study cannot be blinded. Patients will be followed until completion of expansion and exchange for the permanent implant which typically takes 2 to 3 months. Risks factors that have been previously identified to be associated with increased postoperative complications include smoking, obesity, breast size, diabetes, radiation therapy, and expander fill volume will be identified. The final outcome is completion of expansion and exchange to permanent implant.
Standard operative procedure and postoperative care will be done. Both groups will have the same two external drains placed which is standard operative procedure. Complications will be noted at each postoperative clinic visit and entered into a database. Complication rates will be compared between the two groups and associations with risk factors will be analyzed. There will be no cross-over into the other group in case of reconstructive failure. Treatment failures will be treated in the same fashion in the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one-port | Active Comparator | intervention is placement of one-port tissue expander at time of reconstruction |
|
| two-port | Active Comparator | intervention is placement of two-port tissue expander at time of reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergen one-port tissue expander placement | Device | patients will be randomized to receive a one port or two port tissue expander for breast reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant | The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Required Additional Intervention | Number of participants requiring additional intervention following tissue expander placement will be compared between the two arms of the study | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesley Wong, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | One-port | intervention is placement of one-port tissue expander at time of reconstruction Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction |
| FG001 | Two-port | intervention is placement of two-port tissue expander at time of reconstruction AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One-port | intervention is placement of one-port tissue expander at time of reconstruction Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction |
| BG001 | Two-port |
| 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 | Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant | The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared | Posted | Count of Participants | Participants | 3 months |
|
3 months
All-cause mortality was not monitored/assessed.
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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-port | intervention is placement of one-port tissue expander at time of reconstruction Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| re-operation | Surgical and medical procedures | Systematic Assessment | Reoperation for infection or seroma |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lesley Wong | University of Kentucky Division of Plastic Surgery | 859-323-7505 | lesley.wong@uky.edu |
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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 | Jan 17, 2017 | Jul 29, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2017 | Jul 29, 2020 | ICF_001.pdf |
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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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|
| AlloX2 two-port tissue expander placement | Device | patients will be randomized to receive a one port or two port tissue expander for breast reconstruction |
|
|
intervention is placement of two-port tissue expander at time of reconstruction AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 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 | Number | participants |
|
|
|
| Secondary | Number of Participants Who Required Additional Intervention | Number of participants requiring additional intervention following tissue expander placement will be compared between the two arms of the study | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 0 |
| 1 |
| 8 |
| 0 |
| 8 |
| EG001 | Two-port | intervention is placement of two-port tissue expander at time of reconstruction AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction | 0 | 0 | 4 | 12 | 0 | 12 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |