N/A
N=32
Fibrin Glue in Inguinal Lymphadenectomy
Seroma
Bottom Line
View on ClinicalTrials.gov: NCT04666051 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Number of Participants With Seroma Formation — 2; 8 participants — p=0.022
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Application of fibrin glue sealant (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Menoufia University
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Seroma Formation |
2; 8 | 0.022 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04666051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.