Evaluation of SOMAVAC 100 Sustained Vacuum System

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: SOMAVAC 100 Sustained Vacuum System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37402
      • Plastic Surgery Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Up to 25 patients (50 breasts) will be enrolled in this study who are undergoing immediate breast reconstruction after mastectomy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SOMAVAC 100 Sustained Vacuum System; New sustained vacuum system	Device: SOMAVAC 100 Sustained Vacuum System; Evaluate performance of sustained vacuum system compared to manual suction bulbs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Tennessee
• Investigators: Principal Investigator: Mark A Brzezienski, MD, University of Tennessee College of Medicine Chattanooga, Department of Plastic Surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ACTUAL): October 5, 2022
• Study Completion (ACTUAL): October 30, 2022

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (ACTUAL): April 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PSG SOMAVAC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes