Seroma as Procedural ComplicationNCT04554407
Study to Evaluate the Performance of a Sustained Vacuum System
A study testing SOMAVAC® 100 Sustained Vacuum System in people with Seroma as Procedural Complication and Hematoma Postoperative, run by SOMAVAC Medical Solutions at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Seroma as Procedural Complication, Hematoma Postoperative
- What is being tested?
- SOMAVAC® 100 Sustained Vacuum System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to Sep 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 21 years or older;
- Undergoing mastectomy (uni or bilateral), axillary node resection, or inguinal node resection;
- Capable of providing informed consent.
Who cannot join
- 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- Patients who have participated in this trial previously and who were withdrawn;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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Heath Science Center
Memphis, Tennessee, 38106
About this study
Official title: A Non-Randomized, Prospective Study to Evaluate the Performance of a Sustained Vacuum System
The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.
- Being tested
- SOMAVAC® 100 Sustained Vacuum System
- Keywords
- Seroma Following Procedure, Healing Delayed, Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOMAVAC® 100 Sustained Vacuum SystemDevice
The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | All participants receive the SOMAVAC® 100 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.
Time with drains
Determine the length of time drains were used
Measured: 1 - 6 weeks
Surgical site related complications
Evaluate the number of surgical site related complication
Measured: 1 week - 1 year
Secondary outcomes (2)
Patient reported usability of the suction device
Determine patient reported usability of the suction device with the system usability scale
Measured: 1week - 1year
Amount of fluid collected
Determine the total amount of fluid collected
Measured: 1week - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start11 Aug 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Seroma as Procedural ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the SOMAVAC® 100.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOMAVAC Medical Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Tennessee
- Responsible party
- Sponsor
- Investigators
- Martin D Fleming, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554407
- Sponsor's protocol ID
- DOC-201419 Rev B
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Agrawal A, Ayantunde AA, Cheung KL. Concepts of seroma formation and prevention in breast cancer surgery. ANZ J Surg. 2006 Dec;76(12):1088-95. doi: 10.1111/j.1445-2197.2006.03949.x.
PubMed 17199696Carruthers KH, Eisemann BS, Lamp S, Kocak E. Optimizing the closed suction surgical drainage system. Plast Surg Nurs. 2013 Jan-Mar;33(1):38-42; quiz 43-4. doi: 10.1097/PSN.0b013e31828425db.
PubMed 23446508Durai R, Ng PC. How to insert a perfect chest drain. Acta Chir Belg. 2009 Oct;109(5):652-4. doi: 10.1080/00015458.2009.11680510.
PubMed 19994817Janis JE, Khansa L, Khansa I. Strategies for Postoperative Seroma Prevention: A Systematic Review. Plast Reconstr Surg. 2016 Jul;138(1):240-252. doi: 10.1097/PRS.0000000000002245.
PubMed 27348657Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Evidence-based risk factors for seroma formation in breast surgery. Jpn J Clin Oncol. 2006 Apr;36(4):197-206. doi: 10.1093/jjco/hyl019.
PubMed 16684859Lamp S. Closed-suction drain systems in the plastic surgery patient. Plast Surg Nurs. 2011 Oct-Dec;31(4):188-90. doi: 10.1097/PSN.0b013e318238d847. No abstract available.
PubMed 22157612Long LC. The home healthcare nurse as a patient. Home Healthc Nurse. 2013 Jan;31(1):47. doi: 10.1097/NHH.0b013e3182778da2.
PubMed 23238624Phillips BT, Wang ED, Mirrer J, Lanier ST, Khan SU, Dagum AB, Bui DT. Current practice among plastic surgeons of antibiotic prophylaxis and closed-suction drains in breast reconstruction: experience, evidence, and implications for postoperative care. Ann Plast Surg. 2011 May;66(5):460-5. doi: 10.1097/SAP.0b013e31820c0593.
PubMed 21407050Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.
PubMed 21904861Whitson BA, Richardson E, Iaizzo PA, Hess DJ. Not every bulb is a rose: a functional comparison of bulb suction devices. J Surg Res. 2009 Oct;156(2):270-3. doi: 10.1016/j.jss.2009.03.096. Epub 2009 May 8.
PubMed 19691976
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Prospective Study to Evaluate the Performance of a Sustained Vacuum System
- ClinicalTrials.gov ID
- NCT04554407
- Acronym / sponsor ID
- DOC-201419 Rev B
- Keywords
- Seroma Following Procedure, Healing Delayed, Dehiscence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- SOMAVAC Medical SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- University of Tennessee
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 18 Sep 2020 (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 study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the SOMAVAC® 100.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: SOMAVAC® 100 Sustained Vacuum SystemAll participants receive the SOMAVAC® 100 Sustained Vacuum System |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 21 years or older;
- Undergoing mastectomy (uni or bilateral), axillary node resection, or inguinal node resection;
- Capable of providing informed consent.
Key exclusion criteria (7 listed)
- 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;
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 SystemThe SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction. | Device | Treatment Group |
Primary outcome
Time with drains
Time frame: 1 - 6 weeks
Determine the length of time drains were used
Surgical site related complications
Time frame: 1 week - 1 year
Evaluate the number of surgical site related complication
2 secondary outcomes
Patient reported usability of the suction device
Time frame: 1week - 1year
Amount of fluid collected
Time frame: 1week - 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 17199696Agrawal A, Ayantunde AA, Cheung KL. Concepts of seroma formation and prevention in breast cancer surgery. ANZ J Surg. 2006 Dec;76(12):1088-95. doi: 10.1111/j.1445-2197.2006.03949.x.
- Background: PubMed 23446508Carruthers KH, Eisemann BS, Lamp S, Kocak E. Optimizing the closed suction surgical drainage system. Plast Surg Nurs. 2013 Jan-Mar;33(1):38-42; quiz 43-4. doi: 10.1097/PSN.0b013e31828425db.
- Background: PubMed 19994817Durai R, Ng PC. How to insert a perfect chest drain. Acta Chir Belg. 2009 Oct;109(5):652-4. doi: 10.1080/00015458.2009.11680510.
- Background: PubMed 27348657Janis JE, Khansa L, Khansa I. Strategies for Postoperative Seroma Prevention: A Systematic Review. Plast Reconstr Surg. 2016 Jul;138(1):240-252. doi: 10.1097/PRS.0000000000002245.
- Background: PubMed 16684859Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Evidence-based risk factors for seroma formation in breast surgery. Jpn J Clin Oncol. 2006 Apr;36(4):197-206. doi: 10.1093/jjco/hyl019.
- Background: PubMed 22157612Lamp S. Closed-suction drain systems in the plastic surgery patient. Plast Surg Nurs. 2011 Oct-Dec;31(4):188-90. doi: 10.1097/PSN.0b013e318238d847. No abstract available.
- Background: PubMed 23238624Long LC. The home healthcare nurse as a patient. Home Healthc Nurse. 2013 Jan;31(1):47. doi: 10.1097/NHH.0b013e3182778da2.
- Background: PubMed 21407050Phillips BT, Wang ED, Mirrer J, Lanier ST, Khan SU, Dagum AB, Bui DT. Current practice among plastic surgeons of antibiotic prophylaxis and closed-suction drains in breast reconstruction: experience, evidence, and implications for postoperative care. Ann Plast Surg. 2011 May;66(5):460-5. doi: 10.1097/SAP.0b013e31820c0593.
- Background: PubMed 21904861Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.
- Background: PubMed 19691976Whitson BA, Richardson E, Iaizzo PA, Hess DJ. Not every bulb is a rose: a functional comparison of bulb suction devices. J Surg Res. 2009 Oct;156(2):270-3. doi: 10.1016/j.jss.2009.03.096. Epub 2009 May 8.
- Individual participant dataSharing planned: No
Related trials for Seroma as Procedural Complication
Recruiting
Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery
Parotid Neoplasms, Post-operative Complications
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.
Martin D Fleming, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOMAVAC® 100 Sustained Vacuum System in people with Seroma as Procedural Complication and Hematoma Postoperative, run by SOMAVAC Medical Solutions 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 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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?
Results are not available in the source record.
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?
Time with drains (time frame: 1 - 6 weeks). 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?
On the ClinicalTrials.gov record for NCT04554407, which also lists 10 linked publications.
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 28 Sep 2021.