Clinical trial NCT04845256: Evaluation of SOMAVAC 100 Sustained Vacuum System
Official title: Evaluation of SOMAVAC 100 Sustained Vacuum System Versus Manual Suction Bulbs After Mastectomy With Immediate Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 25
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 25 patients (50 breasts) will be enrolled in this study who are undergoing immediate breast reconstruction after mastectomy.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of the SOMAVAC continuous suction device on postoperative fluid drainage after mastectomy reconstruction
timeFrame: Approximately 3 months
measure: The SOMAVAC continuous suction device and seroma development on reconstructed mastectomy patients
timeFrame: approximately 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Plastic Surgery Group
state: Tennessee
Study officials:
affiliation: University of Tennessee College of Medicine Chattanooga, Department of Plastic Surgery
name: Mark A Brzezienski, MD
role: PRINCIPAL_INVESTIGATOR
References: