Study to Evaluate the Performance of a Sustained Vacuum System

Hematoma Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04554407
• Other study ID #: DOC-201419 Rev B
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 11, 2020
• Est. completion date: September 2022

Study information

• Verified date: September 2020
• Source: SOMAVAC Medical Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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• Patients who have participated in this trial previously and who were withdrawn;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

Related Conditions & MeSH terms

• Hematoma
• Hematoma Postoperative
• Seroma
• Seroma as Procedural Complication

Intervention

Device:
• SOMAVAC® 100 Sustained Vacuum System
The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.

Locations

Country	Name	City	State
United States	University of Tennessee Heath Science Center	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SOMAVAC Medical Solutions	University of Tennessee Health Science Center

Country where clinical trial is conducted

United States, 

References & 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. Review. — View 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. — View Citation

Durai R, Ng PC. How to insert a perfect chest drain. Acta Chir Belg. 2009 Oct;109(5):652-4. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time with drains	Determine the length of time drains were used	1 - 6 weeks
Primary	Surgical site related complications	Evaluate the number of surgical site related complication	1 week - 1 year
Secondary	Patient reported usability of the suction device	Determine patient reported usability of the suction device with the system usability scale	1week - 1year
Secondary	Amount of fluid collected	Determine the total amount of fluid collected	1week - 6 weeks