Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Bayer
• Treatments: Fibrin Tissue Adhesive

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.