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Fibrin Melanoma Axillary Node Study in Patients With Melanoma
This study is ongoing, but not recruiting participants.
Study NCT00504582   Information provided by M.D. Anderson Cancer Center
First Received: July 19, 2007   Last Updated: August 11, 2009   History of Changes

July 19, 2007
August 11, 2009
May 2002
May 2010   (final data collection date for primary outcome measure)
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 ]
The goal of this clinical research study is to investigate whether the use of TISSEEL (adhesive substance) can 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: 7 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00504582 on ClinicalTrials.gov Archive Site
 
 
 
Fibrin Melanoma Axillary Node Study in Patients With Melanoma
A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma

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:

  1. To determine the postoperative morbidity rate using fibrin sealant following axillary node 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.

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Melanoma
Drug: Fibrin Sealant
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
115
 
May 2010   (final data collection date for primary outcome measure)

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.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00504582
Paul F. Mansfield, MD/Professor, U.T.M.D. Anderson Cancer Center
GS01-565
M.D. Anderson Cancer Center
 
Principal Investigator: Paul F. Mansfield, MD U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP