Fibrin Melanoma Axillary Node Study in Patients With Melanoma

• Status: Completed
• Trial end date: 2020-04-09
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

1. Part I - Inclusion Criteria, patients that consent to participate.

2. Patients with melanoma who have undergone axillary dissection within the last six months as part of their surgical treatment will be considered for the study.

Exclusion Criteria:

1. Part II - Exclusion Criteria, patients with known hypersensitivity to bovine proteins.

2. Patient has undergone prior radiation therapy to the operative site.

3. Patient is pregnant or lactating.

4. Patient is steroid dependent within prior 6 months.

5. Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.

6. Patient has pre-existing lymphedema.

7. Patient has other pre-existing medical conditions with evidence of organ dysfunction as determined by principal investigator.