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The purpose of this research study is to compare the effectiveness of the Somavac 100 Sustained Vacuum System versus manual section bulbs after immediate breast reconstruction.
Participants will undergo a screening that includes medical history review. Once screening is complete, participants will undergo immediate breast reconstruction per the surgeon's typical protocol. Surgeon will place up to two (2) drain(s) per breast as customary without changing their technique at the end of the surgical procedure. SOMAVAC® 100 Sustained Vacuum System will be attached to the end of the drain(s) on one side of the subject and standard of care manual suction bulbs attached to the other side. Subjects will return to the clinic every 72 hours for visits for the first 1 to 2 weeks, until the drain drops below 25mL, or as instructed by the physician. Each visit will take about 30 minutes. Subjects will have routine phone calls with the clinic to provide their drain output information to help determine when the drains should be removed. This is a study where the standard techniques of closed suction drainage are used for the removal of fluid from a surgical site. Hence, an increased risk related to post-operative care is not anticipated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOMAVAC 100 Sustained Vacuum System | New sustained vacuum system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOMAVAC 100 Sustained Vacuum System | Device | Evaluate performance of sustained vacuum system compared to manual suction bulbs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the SOMAVAC continuous suction device on postoperative fluid drainage after mastectomy reconstruction | Given that patients enrolled will have bilateral reconstruction, one side will have the SOMAVAC continuous suction device and the other side will have standard manual suction bulbs. The fluid drained on each side will be measured in milliliters over 24 hour periods, recorded, and analyzed for any difference. | Approximately 3 months |
| The SOMAVAC continuous suction device and seroma development on reconstructed mastectomy patients | Incidence of postoperative seromas requiring drainage will be recorded for each side. Fluid drained will be measured in milliliters and side differences will be analyzed for statistical significance. | approximately 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 25 patients (50 breasts) will be enrolled in this study who are undergoing immediate breast reconstruction after mastectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Brzezienski, MD | University of Tennessee College of Medicine Chattanooga, Department of Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plastic Surgery Group | Chattanooga | Tennessee | 37402 | United States |
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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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| D017437 |
| Skin and Connective Tissue Diseases |