An interventional study of Glubran 2 in Seroma Following Procedure, sponsored by Omphis Foundation. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Omphis Foundation · Not applicable, Interventional, and Treatment
Axillary lymphadenectomy in breast cancer continues to be a common practice in certain patients. The use of sealants and drains continues to be a source of disagreement among the scientific community. That is why the study was designed to show whether the sealant reduces seroma after axillary lymphadenectomy without drainage.
A study has been designed to assess whether the sealant reduces the rate of symptomatic seroma measured by the number of evacuating punctures. Likewise, the decrease in volume due to the seroma between the two groups and the quality of life of the patients is assessed, given that none of them has a drain
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's planned enrollment of 134 is above the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Omphis Foundation is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain
Other: Glubran 2
No intervention required, only axillary dissection without drain
Application of Glubran 2 sealant (liquid) in axillary hollow
Change in symptomatic seroma
Number of evacuating punctures
Time frame: Up tp 1 year
Number of participants with treatment-related adverse events
Type and number of adverse events
Time frame: Up to 1 year
Seroma volume
Volume measured by ultrasound (cm3 )
Time frame: Day 7 and 14 after surgery
Milliliters of evacuated seroma in case of puncture
Assess if there are differences in the volume of seroma evacuated (milliliters) between groups
Time frame: 7, 14 and 30 day after surgery
Demographic characteristics of patients related to seroma
Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma
Time frame: Up to 1 year
Number of patients with temporary or permanence of disability after operation
Clavien-Dindo classification of morbidity
Time frame: Up to 1 year
Individual's perception of the position in life of the participants
Assess the quality of life after the intervention measured by the EuroQol five dimensions (EQ-5D-5L questionnaire). Descriptive system for health-related quality of life states in adults, consisting of five dimensions. No quality 0 points. Perfect quality 100 points
Time frame: Day 7 and 14 after surgery
Plan to share: No
Started Apr 2022 (actual). Primary completion is estimated for Jun 2025, 38 months after the start.
Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's planned 38 months is above that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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Omphis Foundation