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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.
After being informed of the study including potential risks and benefits, all patients giving consent who meet eligibility requirements will undergo randomization into either the pulsed lavage arm (receive mastectomy pocket wash out using pulsed lavage) or the no pulsed lavage arm (pulsed lavage will not be used). Randomization will occur using a random number generator with even numbers resulting in a pulsed lavage washout and odd numbers resulting in no pulsed lavage washout.
The patients will be followed in clinic for a maximum of 3 months to evaluate the surgical site. The two cohorts will be compared at the end of the study to determine whether there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Lavage Washout | Experimental | This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement and pulsed lavage washout. |
|
| No Pulsed Lavage | Active Comparator | This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Lavage Washout | Other | Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket |
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| Measure | Description | Time Frame |
|---|---|---|
| Post-op Complications | unintended complications that occur post-surgically | up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann C Braswell, BS | Contact | 256-595-3846 | acb98@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard J Fix, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D015413 | Mastectomy, Simple |
| D015625 | Tissue Expansion Devices |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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Two cohorts will be established. One cohort will include patients who undergo pulsed lavage to wash out the mastectomy pocket. The other cohort will include patients who do not receive pulsed lavage.
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Pulsed Lavage is a surgical technique that cannot be masked from the investigators performing the operation.
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| Implant-based breast reconstruction | Procedure | Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket |
|
| Bilateral or unilateral mastectomy | Procedure | Standard of care |
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| Tissue expander | Device | Standard of care |
|
| Acellular dermal matrix | Other | Standard of care |
|
| D013523 | Surgical Equipment |