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Study to Evaluate the Performance of a Sustained Vacuum System

Not Applicable
Conditions
Seroma as Procedural Complication
Hematoma Postoperative
Registration Number
NCT04554407
Lead Sponsor
SOMAVAC Medical Solutions
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
29
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  • Patients who have participated in this trial previously and who were withdrawn;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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Time with drains1 - 6 weeks

Determine the length of time drains were used

Surgical site related complications1 week - 1 year

Evaluate the number of surgical site related complication

Secondary Outcome Measures
NameTimeMethod
Patient reported usability of the suction device1week - 1year

Determine patient reported usability of the suction device with the system usability scale

Amount of fluid collected1week - 6 weeks

Determine the total amount of fluid collected

Trial Locations

Locations (1)

University of Tennessee Heath Science Center

🇺🇸

Memphis, Tennessee, United States

University of Tennessee Heath Science Center
🇺🇸Memphis, Tennessee, United States

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