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Study to Evaluate the Performance of a Sustained Vacuum System

Sponsor
SOMAVAC Medical Solutions (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04554407
Collaborator
University of Tennessee Health Science Center (Other)
29
Enrollment
1
Location
1
Arm
24.7
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: SOMAVAC® 100 Sustained Vacuum System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants receive the SOMAVAC® 100.All participants receive the SOMAVAC® 100.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Non-Randomized, Prospective Study to Evaluate the Performance of a Sustained Vacuum System
Actual Study Start Date :
Aug 11, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Time with drains [1 - 6 weeks]

    Determine the length of time drains were used

  2. Surgical site related complications [1 week - 1 year]

    Evaluate the number of surgical site related complication

Secondary Outcome Measures

  1. Patient reported usability of the suction device [1week - 1year]

    Determine patient reported usability of the suction device with the system usability scale

  2. Amount of fluid collected [1week - 6 weeks]

    Determine the total amount of fluid collected

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Tennessee Heath Science Center Memphis Tennessee United States 38106

Sponsors and Collaborators

  • SOMAVAC Medical Solutions
  • University of Tennessee Health Science Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
SOMAVAC Medical Solutions
ClinicalTrials.gov Identifier:
NCT04554407
Other Study ID Numbers:
  • DOC-201419 Rev B
First Posted:
Sep 18, 2020
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by SOMAVAC Medical Solutions
Seroma Following Procedure
Healing Delayed
Dehiscence
Additional relevant MeSH terms:
Hematoma
Seroma

Study Results

No Results Posted as of Sep 28, 2021