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Fibrin Melanoma Axillary Node Study in Patients With Melanoma

NCT00504582 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2023-05-09

Study results available
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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.

Conditions

Interventions

DRUG

Fibrin Sealant

Tisseel applied externally to the dissected axillary area.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Paul F. Mansfield, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-15
Primary Completion
2020-04-09
Completion
2020-04-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504582 on ClinicalTrials.gov