Using Glubran 2 sealant in axillary lymphadenectomy without drainage
Seroma Control in Axillary Lymphadenectomy With Glubran 2® Without Drain. Multicenter, Prospective, Randomized Clinical Trial. GALA-ND Study (Glu Axillary Lymphadenectomy Ambulatory- no Drain)
This study is testing if using a special surgical glue called Glubran 2 can help breast cancer patients avoid fluid buildup after lymph node surgery without needing drains.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Omphis Foundation Academic / other |
| Locations | 1 site (Mataró) |
| Trial ID | NCT05280353 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Glubran 2, a surgical sealant, in reducing the incidence of seroma formation following axillary lymphadenectomy in breast cancer patients. Participants will undergo the procedure without the use of drains, and the study will measure the number of evacuating punctures required due to symptomatic seroma. Additionally, the study will assess changes in seroma volume and the overall quality of life for patients post-surgery. The goal is to determine if the sealant can improve outcomes compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing conservative surgery for breast cancer that includes axillary lymphadenectomy.
Not a fit: Patients who have undergone mastectomy, previous axillary surgery, or those with significant health issues (ASA 4) may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of seromas and improve recovery experiences for patients undergoing axillary lymphadenectomy.
How similar studies have performed: While the use of sealants in surgical procedures has been explored, this specific application in axillary lymphadenectomy without drainage is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mataró
- Maresme health consortium — Mataró, Spain (Recruiting)
Study contacts
- Principal investigator: Sandra Lopez Gordo, Doctor — Health Consortium Maresme
- Study coordinator: Sandra Lopez Gordo
- Email: slopezgord@csdm.cat
- Phone: 937 41 77 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.