Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients

Completed · Not applicable

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00506311

Run by

M.D. Anderson Cancer Center

People needed

53

Starts

2003-02-01

Expected to finish

2008-03-01

Last updated by the study team

2012-08-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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