Study to Evaluate the Performance of a Sustained Vacuum System

NCT04554407 | Unknown FDA Device

• 1 other identifier: DOC-201419 Rev B
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Seroma as Procedural Complication; Hematoma Postoperative

Keywords

Seroma Following Procedure; Healing Delayed; Dehiscence

Outcome Measures

Primary Outcomes (2)

• Time with drains

  Determine the length of time drains were used

  1 - 6 weeks

• Surgical site related complications

  Evaluate the number of surgical site related complication

  1 week - 1 year

Secondary Outcomes (2)

• Patient reported usability of the suction device

  1week - 1year

• Amount of fluid collected

  1week - 6 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

All participants receive the SOMAVAC® 100 Sustained Vacuum System

Device: SOMAVAC® 100 Sustained Vacuum System

Interventions

SOMAVAC® 100 Sustained Vacuum System DEVICE

The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.

Treatment Group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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• Patients who have participated in this trial previously and who were withdrawn;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

Sponsors & Collaborators

• SOMAVAC Medical Solutions: lead
• University of Tennessee: collaborator

Study Sites (1)

University of Tennessee Heath Science Center

Memphis, Tennessee, 38106, United States

Location

Related Publications (10)

• 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.

  PMID: 17199696 BACKGROUND

• 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.

  PMID: 23446508 BACKGROUND

• 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.

  PMID: 19994817 BACKGROUND

• 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.

  PMID: 27348657 BACKGROUND

• 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.

  PMID: 16684859 BACKGROUND

• 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.

  PMID: 22157612 BACKGROUND

• Long LC. The home healthcare nurse as a patient. Home Healthc Nurse. 2013 Jan;31(1):47. doi: 10.1097/NHH.0b013e3182778da2.

  PMID: 23238624 BACKGROUND

• 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.

  PMID: 21407050 BACKGROUND

• 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.

  PMID: 21904861 BACKGROUND

• 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.

  PMID: 19691976 BACKGROUND

Study Officials

• Martin D Fleming, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants receive the SOMAVAC® 100.

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 18, 2020
• Study Start: August 11, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)