N/A
Completed N=112
Fibrin Melanoma Axillary Node Study in Patients With Melanoma
Source: ClinicalTrials.gov NCT00504582 ↗Enrolled (actual)
112
Serious AEs
3.3%
Results posted
Oct 2021
Primary outcomePrimary: Drain Duration — 23; 21 days
Summary
Primary Objective:
* To determine whether the use of a fibrin sealant applied to axillary soft tissues following node dissection can result in earlier drain removal.
Secondary Objectives:
* To determine the postoperative morbidity rate using fibrin sealant following axillary node dissection.
* To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model.
* 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drain Duration |
23; 21 | — |
| SECONDARY Number of Participants With Infection |
12; 8; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Part I - Inclusion Criteria, patients that consent to participate.
- Patients with melanoma who have undergone axillary dissection within the last six months as part of their surgical treatment will be considered for the study.
Exclusion Criteria
- Part II - Exclusion Criteria, patients with known hypersensitivity to bovine proteins.
- Patient has undergone prior radiation therapy to the operative site.
- Patient is pregnant or lactating.
- Patient is steroid dependent within prior 6 months.
- Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.
- Patient has pre-existing lymphedema.
- Patient has other pre-existing medical conditions with evidence of organ dysfunction as determined by principal investigator.
Data sourced from ClinicalTrials.gov (NCT00504582). 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. Informational only — not medical advice.