Evaluation of SOMAVAC 100 Sustained Vacuum System

February 9, 2023 updated by: University of Tennessee

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Impact of the SOMAVAC continuous suction device on postoperative fluid drainage after mastectomy reconstruction
Time Frame: Approximately 3 months
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
Time Frame: approximately 3 months
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Tennessee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark A Brzezienski, MD, University of Tennessee College of Medicine Chattanooga, Department of Plastic Surgery

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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