Study to Evaluate the Performance of a Sustained Vacuum System

Not Applicable

• Conditions: Seroma as Procedural Complication; Hematoma Postoperative
• Interventions: Device: SOMAVAC® 100 Sustained Vacuum System

• 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

Study Timeline

• Study Start: 2020-08-11
• Status Verified: 2020-09
• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-09-12
• Study First Posted: 2020-09-18
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-28
• Primary Completion: 2022-09
• Study Completion: 2022-09

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• Patients who have participated in this trial previously and who were withdrawn;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

Arm && Interventions

Group	Intervention	Description
Treatment Group	SOMAVAC® 100 Sustained Vacuum System	All participants receive the SOMAVAC® 100 Sustained Vacuum System

Primary Outcome Measures

Name	Time	Method
Time with drains	1 - 6 weeks	Determine the length of time drains were used
Surgical site related complications	1 week - 1 year	Evaluate the number of surgical site related complication

Secondary Outcome Measures

Name	Time	Method
Patient reported usability of the suction device	1week - 1year	Determine patient reported usability of the suction device with the system usability scale
Amount of fluid collected	1week - 6 weeks	Determine the total amount of fluid collected

Trial Locations

Locations (1)

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