CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 121 enrolled
Drug / intervention
Fibrin Sealantdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00504582
NCT00504582N/ACompleted

A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma

M.D. Anderson Cancer Center·interventional·Posted Jul 20, 2007·Updated May 9, 2023

In Brief

A clinical study evaluating Fibrin Sealant for Melanoma. Completed, enrolled 121 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 20, 2007
Enrollment StartMay 15, 2002
Primary CompletionApr 9, 2020
TodayJul 2, 2026
Enrollment to primary: 17.9 yearsPosted 18.9 years ago

Interventions

Fibrin Sealantdrug

Tisseel applied externally to the dissected axillary area.