Clinical trial NCT04554407: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Seroma as Procedural Complication
Hematoma Postoperative
Keywords: Seroma Following Procedure
Healing Delayed
Dehiscence
Lead sponsor: SOMAVAC Medical Solutions
Sponsor class: INDUSTRY
Collaborators: name: University of Tennessee
First posted: 2020-09-18
Enrollment: 29
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive the SOMAVAC® 100.
Primary purpose: PREVENTION

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


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* Patients who have participated in this trial previously and who were withdrawn;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

Primary outcomes:
measure: Time with drains
timeFrame: 1 - 6 weeks
measure: Surgical site related complications
timeFrame: 1 week - 1 year
Secondary outcomes:
measure: Patient reported usability of the suction device
timeFrame: 1week - 1year
measure: Amount of fluid collected
timeFrame: 1week - 6 weeks
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Heath Science Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Martin D Fleming, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.
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.
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citation: Long LC. The home healthcare nurse as a patient. Home Healthc Nurse. 2013 Jan;31(1):47. doi: 10.1097/NHH.0b013e3182778da2.
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.
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.
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.