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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04554407
Other study ID # DOC-201419 Rev B
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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are unlikely to comply with the protocol; - Patients who have participated in this trial previously and who were withdrawn; - Patients with known allergies to contacting materials (i.e. latex, metal, etc.); - Patients who received neoadjuvant chemotherapy or radiotherapy within the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.

Study Design


Related Conditions & MeSH terms


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
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