Study to Evaluate the Performance of a Sustained Vacuum System

September 24, 2021 updated by: SOMAVAC Medical Solutions

A Non-Randomized, Prospective Study to Evaluate the Performance of a Sustained Vacuum System

The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38106
        • University of Tennessee Heath Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Aged 21 years or older;
  • Undergoing mastectomy (uni or bilateral), axillary node resection, or inguinal node resection;
  • Capable of providing informed consent.

Exclusion Criteria:

  • Pregnant or lactating females;
  • Patients on steroids or other immune modulators known to impact healing;
  • Patients who are likely to not complete the study;
  • Patients 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  • Patients who have participated in this trial previously and who were withdrawn;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 3 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Group
All participants receive the SOMAVAC® 100 Sustained Vacuum System
Device: SOMAVAC® 100 Sustained Vacuum System
The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time with drains
Time Frame: 1 - 6 weeks
Determine the length of time drains were used
1 - 6 weeks
Surgical site related complications
Time Frame: 1 week - 1 year
Evaluate the number of surgical site related complication
1 week - 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported usability of the suction device
Time Frame: 1week - 1year
Determine patient reported usability of the suction device with the system usability scale
1week - 1year
Amount of fluid collected
Time Frame: 1week - 6 weeks
Determine the total amount of fluid collected
1week - 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOMAVAC Medical Solutions

Collaborators

University of Tennessee

Investigators

  • Principal Investigator: Martin D Fleming, MD, University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 11, 2020

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

September 6, 2020

First Submitted That Met QC Criteria

September 12, 2020

First Posted (ACTUAL)

September 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC-201419 Rev B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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