Is There a Role for Fibrin Glue (Sealant) in Seroma Reduction After Inguinal Lymphadenectomy?
Phase: NA
Conditions: Seroma
Sponsor: Menoufia University

 
 
 
 
Role for Fibrin Glue (Sealant) in Seroma Reduction After Inguinal Lymphadenectomy; A 
Randomized Controlled Trial 
 
 
 
 
 
 
 
 
 
NCT04666051 
 
 
 
 
 
 
 
 
 
30 October 2020 
 
 
 
 
 
 
 
 
 

Study Protocol 
Clinical background 
Seroma is one of the most frequent complications occurring after ILND as it affects nearly one third of 
these cases. During the past decades, many actions have been tried in the perioperative care to decrease the 
incidence of these complications, as employing well vascularized bulky flaps to obliterate the dead space 
and to protect vessels, great saphenous vein sparing, strict bed rest and fibrin sealant application.  
Objective  
This study aimed to evaluate the role and impact of using fibrin glue to decrease seroma formation in 
patients undergoing inguinal lymph node dissection. 
Study design: 
Thirty-nine patients scheduled to perform Inguinal lymphadenectomy for various causes have been checked 
for eligibility to be enrolled in this prospective, randomized study.  
Methods 
Procedure 
Inguinal lymphadenectomy is planned to be performed including scarifying saphenous vein with sartorius 
muscle transposition flap for protection of femoral vessels, then insertion of non-suction tube drain. All the 
previous steps to be performed similarly in both groups. At this stage, the wound is closed for the control 
group, while fibrin glue is prepared to be applied to the fibrin glue group in a dose of 2mL for 100 cm2 
surface area. Postoperatively, the daily collected drain fluid is measured till the drain is removed when the 
daily drainage was less than 30 ml. The patients is planned to be followed up postoperatively for at least 4 
weeks, to detect the possible clinically encountered complications as seroma, wound infection, or skin flap 
necrosis.  
Data collection 
Patients' demographic data and preexisting co-morbidities is recorded. Operative and pathological data 
regarding defect size, blood transfusion, primary tumor pathology, and number and status of retrieved 
lymph nodes is collected. The occurrence of post-operative seroma was the primary outcome. Other non 
serious adverse effect as hematoma, infection, or skin flap necrosis were recorded and compared between 
the two groups. 
Statistical analysis: 
The normality of distribution of variables is verified by Kolmogorov- Smirnov test. Chi-square test (Fisher 
or Monte Carlo) is used for comparisons between groups for categorical variables. Student t-test was used 
to compare two groups for normally distributed quantitative variables. For not normally distributed 
quantitative variables, Mann Whitney test was used to compare between two groups. P value was set to be 
significant if <0.05.