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Study to Evaluate the Performance of a Sustained Vacuum System

Primary Purpose

Seroma as Procedural Complication, Hematoma Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SOMAVAC® 100 Sustained Vacuum System
Sponsored by
SOMAVAC Medical Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seroma as Procedural Complication focused on measuring Seroma Following Procedure, Healing Delayed, Dehiscence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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  • Patients who have participated in this trial previously and who were withdrawn;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.

Sites / Locations

  • University of Tennessee Heath Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

All participants receive the SOMAVAC® 100 Sustained Vacuum System

Outcomes

Primary Outcome Measures

Time with drains
Determine the length of time drains were used
Surgical site related complications
Evaluate the number of surgical site related complication

Secondary Outcome Measures

Patient reported usability of the suction device
Determine patient reported usability of the suction device with the system usability scale
Amount of fluid collected
Determine the total amount of fluid collected

Full Information

First Posted
September 6, 2020
Last Updated
September 24, 2021
Sponsor
SOMAVAC Medical Solutions
Collaborators
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT04554407
Brief Title
Study to Evaluate the Performance of a Sustained Vacuum System
Official Title
A Non-Randomized, Prospective Study to Evaluate the Performance of a Sustained Vacuum System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOMAVAC Medical Solutions
Collaborators
University of Tennessee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma as Procedural Complication, Hematoma Postoperative
Keywords
Seroma Following Procedure, Healing Delayed, Dehiscence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants receive the SOMAVAC® 100.
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
All participants receive the SOMAVAC® 100 Sustained Vacuum System
Intervention Type
Device
Intervention Name(s)
SOMAVAC® 100 Sustained Vacuum System
Intervention Description
The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.
Primary Outcome Measure Information:
Title
Time with drains
Description
Determine the length of time drains were used
Time Frame
1 - 6 weeks
Title
Surgical site related complications
Description
Evaluate the number of surgical site related complication
Time Frame
1 week - 1 year
Secondary Outcome Measure Information:
Title
Patient reported usability of the suction device
Description
Determine patient reported usability of the suction device with the system usability scale
Time Frame
1week - 1year
Title
Amount of fluid collected
Description
Determine the total amount of fluid collected
Time Frame
1week - 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin D Fleming, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Heath Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17199696
Citation
Agrawal A, Ayantunde AA, Cheung KL. Concepts of seroma formation and prevention in breast cancer surgery. ANZ J Surg. 2006 Dec;76(12):1088-95. doi: 10.1111/j.1445-2197.2006.03949.x.
Results Reference
background
PubMed Identifier
23446508
Citation
Carruthers KH, Eisemann BS, Lamp S, Kocak E. Optimizing the closed suction surgical drainage system. Plast Surg Nurs. 2013 Jan-Mar;33(1):38-42; quiz 43-4. doi: 10.1097/PSN.0b013e31828425db.
Results Reference
background
PubMed Identifier
19994817
Citation
Durai R, Ng PC. How to insert a perfect chest drain. Acta Chir Belg. 2009 Oct;109(5):652-4. doi: 10.1080/00015458.2009.11680510.
Results Reference
background
PubMed Identifier
27348657
Citation
Janis JE, Khansa L, Khansa I. Strategies for Postoperative Seroma Prevention: A Systematic Review. Plast Reconstr Surg. 2016 Jul;138(1):240-252. doi: 10.1097/PRS.0000000000002245.
Results Reference
background
PubMed Identifier
16684859
Citation
Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Evidence-based risk factors for seroma formation in breast surgery. Jpn J Clin Oncol. 2006 Apr;36(4):197-206. doi: 10.1093/jjco/hyl019.
Results Reference
background
PubMed Identifier
22157612
Citation
Lamp S. Closed-suction drain systems in the plastic surgery patient. Plast Surg Nurs. 2011 Oct-Dec;31(4):188-90. doi: 10.1097/PSN.0b013e318238d847. No abstract available.
Results Reference
background
PubMed Identifier
23238624
Citation
Long LC. The home healthcare nurse as a patient. Home Healthc Nurse. 2013 Jan;31(1):47. doi: 10.1097/NHH.0b013e3182778da2.
Results Reference
background
PubMed Identifier
21407050
Citation
Phillips BT, Wang ED, Mirrer J, Lanier ST, Khan SU, Dagum AB, Bui DT. Current practice among plastic surgeons of antibiotic prophylaxis and closed-suction drains in breast reconstruction: experience, evidence, and implications for postoperative care. Ann Plast Surg. 2011 May;66(5):460-5. doi: 10.1097/SAP.0b013e31820c0593.
Results Reference
background
PubMed Identifier
21904861
Citation
Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.
Results Reference
background
PubMed Identifier
19691976
Citation
Whitson BA, Richardson E, Iaizzo PA, Hess DJ. Not every bulb is a rose: a functional comparison of bulb suction devices. J Surg Res. 2009 Oct;156(2):270-3. doi: 10.1016/j.jss.2009.03.096. Epub 2009 May 8.
Results Reference
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Study to Evaluate the Performance of a Sustained Vacuum System

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