Study to Evaluate the Performance of a Sustained Vacuum System
NCT ID: NCT04554407
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
29 participants
INTERVENTIONAL
2020-08-11
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Treatment Group
All participants receive the SOMAVAC® 100 Sustained Vacuum System
SOMAVAC® 100 Sustained Vacuum System
The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.
Interventions
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SOMAVAC® 100 Sustained Vacuum System
The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.
Eligibility Criteria
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Inclusion Criteria
* Undergoing mastectomy (uni or bilateral), axillary node resection, or inguinal node resection;
* Capable of providing informed consent.
Exclusion Criteria
* 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* Patients who have participated in this trial previously and who were withdrawn;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.
21 Years
FEMALE
Yes
Sponsors
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University of Tennessee
OTHER
SOMAVAC Medical Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Martin D Fleming, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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University of Tennessee Heath Science Center
Memphis, Tennessee, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Long LC. The home healthcare nurse as a patient. Home Healthc Nurse. 2013 Jan;31(1):47. doi: 10.1097/NHH.0b013e3182778da2.
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.
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.
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.
Other Identifiers
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DOC-201419 Rev B
Identifier Type: -
Identifier Source: org_study_id
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