Cyanoacrylate glue in breast surgery. Can cyanoacrylate glue reduce seroma after axillary dissection?

GLUBreast Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43919783

Enrollment

200

Registered

2024-08-19

Start date

2018-04-24

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of post-operative seroma after axillary dissection in patients with breast cancer Surgery

Interventions

The study is a prospective randomized single-center study enrolling patients who meet inclusion criteria. Patients will be assigned either an Experimental Arm or a Control Arm by a random allocation p

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female gender 2. 18 years of age or older 3. New diagnosis of invasive breast cancer confirmed by core needle biopsy 4. Palpable and positive axillary lymph nodes requiring axillary dissection 5. Patients suitable for breast-conserving surgery (BCS) or modified radical mastectomy (MRM) without reconstruction 6. Ability of understanding and sign the informed consent

Exclusion criteria

Exclusion criteria: 1. Male gender 2. Treated with neo-adjuvant chemotherapy 3. Scheduled for breast reconstruction 4. Previously treated with radiation therapy to the chest wall for lymphoma 5. Inability to understand and sign the informed consent

Design outcomes

Primary

Measure	Time frame
Efficacy of cyanoacrylate glue to prevent post-operative seroma in breast surgery measured using the total volume of fluid drained at days 7, 15 and 21	—

Secondary

Measure	Time frame
The following secondary outcome measures were assessed using covariate data obtained from patient medical records: 1. Total volume of seroma drained (ml) correlation to BMI (Kg/m2) in all visits at days 7, 15, and 21 till complete healing 2. Total volume of seroma drained (ml) correlation to breast-conserving surgery or total mastectomy in both arms in all visits at days 7, 15, and 21 till complete healing 3. Adverse events were reported as an occurrence at least one visit per patient and were measured as the presence or absence of fever (> 37.2 C), pain ( measured using the visual analogue score (VAS) 0 to 10 at baseline, and in all visits during 90 days of follow up), skin dehiscence, skin redness. 4. The rate of infection was measured using the presence or absence of fever and the need for post-operative antibiotics during 90 days of follow-up; hospital re-admission rate and re-operation were measured in numbers and percentages.	—

Measure

Time frame

The following secondary outcome measures were assessed using covariate data obtained from patient medical records: 1. Total volume of seroma drained (ml) correlation to BMI (Kg/m2) in all visits at days 7, 15, and 21 till complete healing 2. Total volume of seroma drained (ml) correlation to breast-conserving surgery or total mastectomy in both arms in all visits at days 7, 15, and 21 till complete healing 3. Adverse events were reported as an occurrence at least one visit per patient and were measured as the presence or absence of fever (> 37.2 C), pain ( measured using the visual analogue score (VAS) 0 to 10 at baseline, and in all visits during 90 days of follow up), skin dehiscence, skin redness. 4. The rate of infection was measured using the presence or absence of fever and the need for post-operative antibiotics during 90 days of follow-up; hospital re-admission rate and re-operation were measured in numbers and percentages.

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Countries

Italy

Contacts

Public ContactEmanuela Esposito

emanuela.esposito@istitutotumori.na.it+39 08117770638

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026