Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients

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.

Timeline

Start

2003-02

Primary completion

2007-12

Completion

2008-03

Publications

• Mortenson MM, Xing Y, Weaver S, Lee JE, Gershenwald JE, Lucci A, Mansfield PF, Ross MI, Cormier JN. Fibrin sealant does not decrease seroma output or time to drain removal following inguino-femoral lymph node dissection in melanoma patients: a randomized controlled trial (NCT00506311). World J Surg Oncol. 2008 Jun 18;6:63. doi: 10.1186/1477-7819-6-63.

Drugs

Indications