Clinical trial · Interventional
Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients
A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: 1\. To determine whether the use of a fibrin sealant applied to superficial groin soft tissues following node dissection can result in decreased cumulative postoperative drainage, earlier drain removal, and lower incidence of seroma. Secondary Objectives: 1. To determine the postoperative morbidity rate using fibrin sealant following superficial groin dissection. 2. To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model. 3. To determine if serum levels, lymphatic fluids level, or cutaneous expression of vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3) correlates with nodal tumor burden or development of lymphedema in patients with melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fibrin Sealant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fibrin Sealant
- interventionNames
- Drug: Fibrin Sealant
- type
- NO_INTERVENTION
- label
- No Fibrin Sealant
Primary outcomes (1)
- measure
- Time-to-Drain Removal
- timeFrame
- From surgery to 30 days post surgery
- description
- The superficial groin drain will be removed once cumulative serous drainage volume 30 ml / 24 hours for 2 days or maximum of = or \< 30 days has elapsed since surgery. Time calculated as days from installation of drain at first day of surgery to removal.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Part I - Inclusion Criteria Patients that consent to participate. * Patients with melanoma who have undergone superficial node dissection (with or without a concurrent deep (ilioinguinal) node dissection within the last six months as part of their surgical treatment will be considered for the study. * Part II- Inclusion Criteria Patients that consent to participate. * Patients with melanoma for which a superficial node dissection is indicated (with or without a concurrent deep (ilioinguinal) node dissection. Exclusion Criteria: * Part II - Exclusion Criteria Patients with known hypersensitivity to bovine proteins. * Patient has undergone prior radiation therapy to the operative site (groin). * Patient is pregnant or lactating. * Patient is steroid dependent within last 6 months. * Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation. * Patients with pre-existing lymphedema. * Patients with other pre-existing medical conditions as per the discretion of the principal investigator.
References
Publications (1)
- DERIVEDMortenson MM, Xing Y, Weaver S, Lee JE, Gershenwald JE, Lucci A, Mansfield PF, Ross MI, Cormier JN. Fibrin sealant does not decrease seroma output or time to drain removal following inguino-femoral lymph node dissection in melanoma patients: a randomized controlled trial (NCT00506311). World J Surg Oncol. 2008 Jun 18;6:63. doi: 10.1186/1477-7819-6-63. PMID 18564433