Study to Evaluate the Performance of a Sustained Vacuum System (NCT04554407) | Clinical Trial Compass
UnknownNot Applicable
Study to Evaluate the Performance of a Sustained Vacuum System
United States29 participantsStarted 2020-08-11
Plain-language summary
The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.
Who can participate
Age range21 Years
SexFEMALE
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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* Patients who have participated in this trial previously and who were withdrawn;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.