Breast CancerNCT04845256
Evaluation of SOMAVAC 100 Sustained Vacuum System
An observational study of Breast Cancer, run by University of Tennessee at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SOMAVAC 100 Sustained Vacuum System
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Up to 25 patients (50 breasts) will be enrolled in this study who are undergoing immediate breast reconstruction after mastectomy.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Patients who have participated in this trial previously and who were withdrawn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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of SOMAVAC 100 Sustained Vacuum System Versus Manual Suction Bulbs After Mastectomy With Immediate Breast Reconstruction
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- SOMAVAC 100 Sustained Vacuum System
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOMAVAC 100 Sustained Vacuum SystemDevice
Evaluate performance of sustained vacuum system compared to manual suction bulbs
| Study group | Role | What they receive |
|---|---|---|
| SOMAVAC 100 Sustained Vacuum System | New sustained vacuum system Receives: Device: SOMAVAC 100 Sustained Vacuum System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 3 months
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.
Measured: approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 May 2021
- Primary completion5 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Brzezienski, MD, Principal investigator, University of Tennessee College of Medicine Chattanooga, Department of Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845256
- Sponsor's protocol ID
- PSG SOMAVAC
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SOMAVAC 100 Sustained Vacuum System Versus Manual Suction Bulbs After Mastectomy With Immediate Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04845256
- Acronym / sponsor ID
- PSG SOMAVAC
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOMAVAC 100 Sustained Vacuum System | – | Device: SOMAVAC 100 Sustained Vacuum SystemNew sustained vacuum system |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 25 patients (50 breasts) will be enrolled in this study who are undergoing immediate breast reconstruction after mastectomy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOMAVAC 100 Sustained Vacuum SystemEvaluate performance of sustained vacuum system compared to manual suction bulbs | Device | SOMAVAC 100 Sustained Vacuum System |
Primary outcome
Impact of the SOMAVAC continuous suction device on postoperative fluid drainage after mastectomy reconstruction
Time frame: Approximately 3 months
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.
The SOMAVAC continuous suction device and seroma development on reconstructed mastectomy patients
Time frame: approximately 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Brzezienski, MD principal investigator
University of Tennessee College of Medicine Chattanooga, Department of Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the SOMAVAC continuous suction device on postoperative fluid drainage after mastectomy reconstruction (time frame: Approximately 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023; AzTrials last refreshed its copy on 2 Nov 2026.