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Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients

NCT00506311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2012-08-02

No results posted yet for this study

Summary

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

Interventions

DRUG

Fibrin Sealant

Tisseel applied externally to the dissected groin area.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Janice N. Cormier, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2007-12-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Diseases
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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 NCT00506311 on ClinicalTrials.gov