NCT04666051: Fibrin Glue in Inguinal Lymphadenectomy

Summary

Seroma is one of the most common encountered morbidities after inguinal lymph node dissection (ILND). It can cause not only much nuisance to both patients and doctors but also its presence can lead to many complications. This study aimed at evaluation of the role and effect of using fibrin glue on seroma reduction in patients undergoing ILND. Thirty-two patient have undergone ILND for various causes. The patients were randomized into two groups; 16 ILND in each. In one group, fibrin glue sealant was applied with a dose of 2ml per 100 cm2 surface area then drain placement was performed. Whereas, in the control group, only drain placement was used. Preoperative, operative and postoperative data were recorded and analyzed.

Timeline

Start: 2015-05
Primary completion: 2020-10
Completion: 2020-10

Outcome

Met primary endpoint

registry NUMBER Fibrin Glue: 2 participants NUMBER Control: 8 participants analysis (superiority test); Fibrin Glue vs Control; p = 0.022; Chi-squared NCT04666051 ↗

Publications

Background Buda A, Fruscio R, Pirovano C, Signorelli M, Betti M, Milani R. The use of TachoSil for the prevention of postoperative complications after groin dissection in cases of gynecologic malignancy. Int J Gynaecol Obstet. 2012 Jun;117(3):217-9. doi: 10.1016/j.ijgo.2011.12.021. Epub 2012 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fibrin glue sealant	Unknown	2 ml	—

Indications

No indication recorded.