Study to Evaluate the Performance of a Sustained Vacuum System

A Non-Randomized, Prospective Study to Evaluate the Performance of a Sustained Vacuum System

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04554407

Enrollment

Registered

2020-09-18

Start date

2020-08-11

Completion date

2022-09-30

Last updated

2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematoma Postoperative, Seroma as Procedural Complication

Keywords

Seroma Following Procedure, Healing Delayed, Dehiscence

Brief summary

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

Interventions

DEVICESOMAVAC® 100 Sustained Vacuum System

The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

All participants receive the SOMAVAC® 100.

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Yes

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are unlikely to comply with the protocol; * Patients who have participated in this trial previously and who were withdrawn; * Patients with known allergies to contacting materials (i.e. latex, metal, etc.); * Patients who received neoadjuvant chemotherapy or radiotherapy within the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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026