Fibrin Melanoma Axillary Node Study in Patients With Melanoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00504582

Purpose

Primary Objective:

1. 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.

Condition	Intervention
Melanoma	Drug: Fibrin Sealant

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Beriplast Fibrin

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Use of TISSEEL (adhesive substance) to decrease the rate of seroma (fluid build-up) at the site of surgery, thus decreasing the time it takes before the drain can be removed. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	115
Study Start Date:	May 2002
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fibrin Sealant: Experimental	Drug: Fibrin Sealant Tisseel applied externally to the dissected axillary area.
No Fibrin Sealant: No Intervention

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504582

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Paul F. Mansfield, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Paul F. Mansfield, MD/Professor )
Study ID Numbers:	GS01-565
Study First Received:	July 19, 2007
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00504582 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Axillary Node Dissection
Fibrin Sealant
Tisseel
Melanoma
Seroma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Coagulants
Fibrin Tissue Adhesive
Neoplasms, Nerve Tissue
Hematologic Agents
Pharmacologic Actions
Hemostatics

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 27, 2009