Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain
- Conditions
- Seroma Following Procedure
- Interventions
- Other: Glubran 2
- Registration Number
- NCT05280353
- Lead Sponsor
- Omphis Foundation
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 134
- Over 18 years old
- Conservative surgery for breast cancer with associated axillary lymphadenectomy
- Mastectomy
- History of axillary surgery or ipsilateral axillary radiotherapy
- ASA 4 patients. (ASA 3 patients selected)
- Lack of adequate cognitive capacity and/or signed informed consent
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description lymphadenectomy without drainage and with Glubran Glubran 2 Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events Up to 1 year Type and number of adverse events
Change in symptomatic seroma Up tp 1 year Number of evacuating punctures
- Secondary Outcome Measures
Name Time Method Demographic characteristics of patients related to seroma Up to 1 year Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma
Number of patients with temporary or permanence of disability after operation Up to 1 year Clavien-Dindo classification of morbidity
Individual's perception of the position in life of the participants Day 7 and 14 after surgery 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
Seroma volume Day 7 and 14 after surgery Volume measured by ultrasound (cm3 )
Milliliters of evacuated seroma in case of puncture 7, 14 and 30 day after surgery Assess if there are differences in the volume of seroma evacuated (milliliters) between groups
Trial Locations
- Locations (1)
Maresme health consortium
🇪🇸Mataró, Spain