Seroma Following Procedure
Conditions
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
Interventions
OTHERGlubran 2
Application of Glubran 2 sealant (liquid) in axillary hollow
Sponsors
Consorci Sanitari del Maresme
Omphis Foundation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
MULTICENTRIC, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years old * Conservative surgery for breast cancer with associated axillary lymphadenectomy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptomatic seroma | Up tp 1 year | Number of evacuating punctures |
| Number of participants with treatment-related adverse events | Up to 1 year | Type and number of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Seroma volume | Day 7 and 14 after surgery | Volume measured by ultrasound (cm3 ) |
| 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 |
| Number of patients with temporary or permanence of disability after operation | Up to 1 year | Clavien-Dindo classification of morbidity |
| 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 |
Countries
Spain
Contacts
Primary ContactSandra Lopez Gordo
Outcome results
None listed