Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05280353

Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Seroma Following Procedure

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maresme health consortium

Mataró, Spain

Location status: Recruiting

Location contact

Sandra lopez gordo

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glubran 2

Other

Application of Glubran 2 sealant (liquid) in axillary hollow

Primary outcomes

  1. Change in symptomatic seroma

    Time frame: Up tp 1 year

    Number of evacuating punctures

  2. Number of participants with treatment-related adverse events

    Time frame: Up to 1 year

    Type and number of adverse events

Secondary outcomes

  1. Seroma volume

    Time frame: Day 7 and 14 after surgery

    Volume measured by ultrasound (cm3 )

  2. Milliliters of evacuated seroma in case of puncture

    Time frame: 7, 14 and 30 day after surgery

    Assess if there are differences in the volume of seroma evacuated (milliliters) between groups

  3. Demographic characteristics of patients related to seroma

    Time frame: Up to 1 year

    Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma

  4. Number of patients with temporary or permanence of disability after operation

    Time frame: Up to 1 year

    Clavien-Dindo classification of morbidity

  5. Individual's perception of the position in life of the participants

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra Lopez Gordo

CONTACT

[email protected]

937 41 77 00 ext. 1141

Sponsors and collaborators

Lead sponsor

Omphis Foundation

Other

Collaborators

  • Consorci Sanitari del Maresme

Registry information

Official study title

Seroma Control in Axillary Lymphadenectomy With Glubran 2® Without Drain. Multicenter, Prospective, Randomized Clinical Trial. GALA-ND Study (Glu Axillary Lymphadenectomy Ambulatory- no Drain)

Acronym: GALA

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 15, 2022
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.