Fibrin Melanoma Axillary Node Study in Patients With Melanoma

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Patients in this study are scheduled to have axillary node dissection as part of their surgery for treatment of their melanoma. Within 2 weeks before entry into the study, patients will have a complete physical exam and medical history. These patients will be randomly assigned (as in the toss of a coin) to one of two groups. Patients in one group will receive TISSEEL applied externally to the dissected axillary area. Patients in the other group will receive no fibrin sealant. For patients who are admitted to the hospital, the surgical site will be monitored by the surgeon for evidence of wound complications in the first 24 hours after surgery. At the time of discharge from the hospital, patients will be instructed in drain care and how to measure the drainage each day until the drain is removed. The contents of the drain will be collected from patients during the first day after surgery, during the first return follow-up visit to M.D. Anderson Cancer Center, and during drain removal (unless these latter 2 dates are the same). Follow-up wound exams will be performed by the local primary physician or in the M.D. Anderson Melanoma Clinic between 1-4 weeks and 6 weeks after surgery. Participation will be over at the 6-week follow-up. THIS IS AN INVESTIGATIONAL STUDY. The sealant is FDA approved, though its use in this study is experimental. About 115 patients will take part in this study. All will be enrolled at M. D. Anderson.

Official Title
-----------------
A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: Fibrin Sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Part I - Inclusion Criteria, patients that consent to participate. 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: Part II - Exclusion Criteria, patients with known hypersensitivity to bovine proteins. Patient has undergone prior radiation therapy to the operative site. Patient is pregnant or lactating. Patient is steroid dependent within prior 6 months. Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation. Patient has pre-existing lymphedema. Patient has other pre-existing medical conditions with evidence of organ dysfunction as determined by principal investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibrin Sealant<br>Tisseel applied externally to the dissected axillary area. | Drug: Fibrin Sealant<br>* Tisseel applied externally to the dissected axillary area.<br>* Other names: Tisseel;|
| No Intervention: No Fibrin Sealant<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drain Duration | Number of days drain was in place | from surgery until drain removed, up to 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Infection | Number of participants with any signs of infection noted following surgery requiring intervention. | after surgery until the wound is healed, up to 30 days whichever is longer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axillary Node Dissection, Fibrin Sealant, Tisseel, Melanoma, Seroma