Evaluation of SOMAVAC 100 Sustained Vacuum System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of SOMAVAC 100 Sustained Vacuum System Versus Manual Suction Bulbs After Mastectomy With Immediate Breast Reconstruction

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: SOMAVAC 100 Sustained Vacuum System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 21 years or older; undergoing immediate pre-pectoral breast reconstruction after mastectomy (bilateral) with tissue expanders or implant Capable of providing informed consent Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent. Exclusion Criteria: Reconstruction is not post-mastectomy Pregnant or lactating females Patients needing more than 2 drains per breast Patients on steroids or other immune modulators known to impact healing Patients who are likely to not complete the study Patient who, in the opinion of the investigator, are unlikely to comply with the protocol Patients who have participated in this trial previously and who were withdrawn Patients with known allergies to contacting materials (i.e. latex, metal, etc.) Patients who received neoadjuvant chemotherapy or radiotherapy within the last 6 months Has any medical condition such as obesity (BMI>40), uncontrolled diabetes (HbA1c>7%) and/or immunosuppression.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SOMAVAC 100 Sustained Vacuum System<br>New sustained vacuum system | Device: SOMAVAC 100 Sustained Vacuum System<br>* Evaluate performance of sustained vacuum system compared to manual suction bulbs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |