Study to Evaluate the Performance of a Sustained Vacuum System

SOMAVAC Medical Solutions

Status: Unknown

Conditions: Hematoma Postoperative; Seroma as Procedural Complication

Treatments: Device: SOMAVAC® 100 Sustained Vacuum System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04554407

DOC-201419 Rev B

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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• Patients who have participated in this trial previously and who were withdrawn;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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

Treatment Group

Experimental group

Description:

All participants receive the SOMAVAC® 100 Sustained Vacuum System

Treatment:

Device: SOMAVAC® 100 Sustained Vacuum System