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Fibrin Glue in Inguinal Lymphadenectomy

Is There a Role for Fibrin Glue (Sealant) in Seroma Reduction After Inguinal Lymphadenectomy?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04666051
Enrollment
32
Registered
2020-12-14
Start date
2015-05-31
Completion date
2020-10-31
Last updated
2022-08-30

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

Conditions

Seroma

Keywords

Fibrin glue, Seroma, Inguinal lymphadenectomy, Wound complication

Brief 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.

Detailed description

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. Realizing the underlying pathology for seroma formation is the key point in its prevention. Thirty-nine patients scheduled to perform Inguinal lymphadenectomy for various causes have been checked for eligibility to be enrolled in this prospective, randomized study. Thirty-two patients have met the inclusion criteria. Inguinal lymphadenectomy has been performed including scarifying saphenous vein. Sartorius muscle transposition flap was routinely performed for protection of femoral vessels, then an 18 French conventional non-suction tube drain was inserted in all patients. All the previous steps were similar in both groups. At this stage, the wound was closed for the control group, while fibrin glue was 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 was measured till the drain was removed when the daily drainage was less than 30 ml. Then the patients were 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. Patients' demographic data and preexisting co-morbidities were recorded. Operative and pathological data regarding defect size, blood transfusion, primary tumor pathology, and number and status of retrieved lymph nodes were 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. The normality of distribution of variables was verified by Kolmogorov- Smirnov test. Chi-square test (Fisher or Monte Carlo) was 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.

Interventions

BIOLOGICALApplication of fibrin glue sealant

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Patients scheduled to perform ILND for various causes

Exclusion criteria

* BMI more than 35, * Uncompensated diabetes * Advanced liver disease * Previous history of surgery and/or irradiation to the inguinal region * Preoperative chemotherapy * Significant coagulation disorders * Platelet counts \<100,000/mL. * Use of systemic steroids or anticoagulants.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Seroma Formation4 weeks postpertivelyCollection of serous fluid under the wound flaps. According to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0, Grade 2 and Grade 3 were considered. Grade 2 indicates it is symptomatic; simple aspiration indicated. Grade 3 indicates it is symptomatic, elective radiologic or operative intervention indicated

Participant flow

Participants by arm

ArmCount
Fibrin Glue
A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain. Application of fibrin glue sealant
16
Control
Lymphadenctomy wound was closed after insertion of a drain,
16
Total32

Baseline characteristics

CharacteristicFibrin GlueControlTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants2 Participants4 Participants
Age, Categorical
Between 18 and 65 years
14 Participants14 Participants28 Participants
Age, Continuous56.40 years
STANDARD_DEVIATION 8.16
55.94 years
STANDARD_DEVIATION 8.1
56.19 years
STANDARD_DEVIATION 8
Inguinal lymphadenectomy16 participants16 participants32 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
16 Participants16 Participants32 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Egypt
16 Participants16 Participants32 Participants
Sex: Female, Male
Female
4 Participants6 Participants10 Participants
Sex: Female, Male
Male
12 Participants10 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 16
other
Total, other adverse events
3 / 169 / 16
serious
Total, serious adverse events
0 / 160 / 16

Outcome results

Primary

Number of Participants With Seroma Formation

Collection of serous fluid under the wound flaps. According to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0, Grade 2 and Grade 3 were considered. Grade 2 indicates it is symptomatic; simple aspiration indicated. Grade 3 indicates it is symptomatic, elective radiologic or operative intervention indicated

Time frame: 4 weeks postpertively

Population: Serum formation has been looked for

ArmMeasureValue (NUMBER)
Fibrin GlueNumber of Participants With Seroma Formation2 participants
ControlNumber of Participants With Seroma Formation8 participants
p-value: 0.022Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026