An interventional study of SOMAVAC® 100 Sustained Vacuum System in Seroma as Procedural Complication and Hematoma Postoperative, sponsored by SOMAVAC Medical Solutions. Status unknown at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by SOMAVAC Medical Solutions · Not applicable, Interventional, and Prevention
The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.
109 studies on the registry are indexed under Hematoma; 19 are open to participants now.
This study's enrollment of 29 is below the median of 107 across 83 interventional studies indexed under Hematoma.
Browse Hematoma studies →This is the only study on the registry with SOMAVAC Medical Solutions as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants receive the SOMAVAC® 100 Sustained Vacuum System
Device: SOMAVAC® 100 Sustained Vacuum System
The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.
Time with drains
Determine the length of time drains were used
Time frame: 1 - 6 weeks
Surgical site related complications
Evaluate the number of surgical site related complication
Time frame: 1 week - 1 year
Patient reported usability of the suction device
Determine patient reported usability of the suction device with the system usability scale
Time frame: 1week - 1year
Amount of fluid collected
Determine the total amount of fluid collected
Time frame: 1week - 6 weeks
Plan to share: No
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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