Evaluation of SOMAVAC 100 Sustained Vacuum System

Breast Cancer Clinical Trial

Official title:

Evaluation of SOMAVAC 100 Sustained Vacuum System Versus Manual Suction Bulbs After Mastectomy With Immediate Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845256
• Other study ID #: PSG SOMAVAC
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: April 2021
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research study is to compare the effectiveness of the Somavac 100 Sustained Vacuum System versus manual section bulbs after immediate breast reconstruction.

Description:

Participants will undergo a screening that includes medical history review. Once screening is complete, participants will undergo immediate breast reconstruction per the surgeon's typical protocol. Surgeon will place up to two (2) drain(s) per breast as customary without changing their technique at the end of the surgical procedure. SOMAVAC® 100 Sustained Vacuum System will be attached to the end of the drain(s) on one side of the subject and standard of care manual suction bulbs attached to the other side. Subjects will return to the clinic every 72 hours for visits for the first 1 to 2 weeks, until the drain drops below 25mL, or as instructed by the physician. Each visit will take about 30 minutes. Subjects will have routine phone calls with the clinic to provide their drain output information to help determine when the drains should be removed. This is a study where the standard techniques of closed suction drainage are used for the removal of fluid from a surgical site. Hence, an increased risk related to post-operative care is not anticipated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 30, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Aged 21 years or older; undergoing immediate pre-pectoral breast reconstruction after mastectomy (bilateral) with tissue expanders or implant
• Capable of providing informed consent
• Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.

Exclusion Criteria:

• Reconstruction is not post-mastectomy
• Pregnant or lactating females
• Patients needing more than 2 drains per breast
• Patients on steroids or other immune modulators known to impact healing
• Patients who are likely to not complete the study
• Patient 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 6 months
• Has any medical condition such as obesity (BMI>40), uncontrolled diabetes (HbA1c>7%) and/or immunosuppression.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• SOMAVAC 100 Sustained Vacuum System
Evaluate performance of sustained vacuum system compared to manual suction bulbs

Locations

Country	Name	City	State
United States	Plastic Surgery Group	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of the SOMAVAC continuous suction device on postoperative fluid drainage after mastectomy reconstruction	Given that patients enrolled will have bilateral reconstruction, one side will have the SOMAVAC continuous suction device and the other side will have standard manual suction bulbs. The fluid drained on each side will be measured in milliliters over 24 hour periods, recorded, and analyzed for any difference.	Approximately 3 months
Primary	The SOMAVAC continuous suction device and seroma development on reconstructed mastectomy patients	Incidence of postoperative seromas requiring drainage will be recorded for each side. Fluid drained will be measured in milliliters and side differences will be analyzed for statistical significance.	approximately 3 months