Evaluation of SOMAVAC 100 Sustained Vacuum System

NCT04845256 | Completed FDA Device

• 1 other identifier: PSG SOMAVAC
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

SOMAVAC 100 Sustained Vacuum System

New sustained vacuum system

Device: SOMAVAC 100 Sustained Vacuum System

Interventions

SOMAVAC 100 Sustained Vacuum System DEVICE

Evaluate performance of sustained vacuum system compared to manual suction bulbs

SOMAVAC 100 Sustained Vacuum System

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Plastic Surgery Group

Chattanooga, Tennessee, 37402, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark A Brzezienski, MD

  University of Tennessee College of Medicine Chattanooga, Department of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 14, 2021
• Study Start: May 1, 2021
• Primary Completion: October 5, 2022
• Study Completion: October 30, 2022
• Last Updated: February 13, 2023

Record last verified: 2021-04

Locations

US (1)