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Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: M.D. Anderson Cancer Center
Bayer
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00506311
  Purpose

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.

Condition Intervention
Melanoma
Drug: Fibrin Sealant

MedlinePlus related topics:   Cancer    Melanoma   

ChemIDplus related topics:   Fibrin    Beriplast   

U.S. FDA Resources

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 Superficial Groin Dissection in Patients With Melanoma

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

Primary Outcome Measures:
  • 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: 6 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:   58
Study Start Date:   February 2003
Estimated Primary Completion Date:   February 2009 (Final data collection date for primary outcome measure)

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

Detailed Description:

Patients in this study are scheduled to have groin 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 groin 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.

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 after the 6-week follow-up.

This is an investigational study. The sealant is FDA approved, though its use in this study is experimental. About 58 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 superficial node dissection (with or without a concurrent deep (ilioinguinal) node dissection within the last six months as part of their surgical treatment will be considered for the study.
  • Part II- Inclusion Criteria Patients that consent to participate.
  • Patients with melanoma for which a superficial node dissection is indicated (with or without a concurrent deep (ilioinguinal) node dissection.

Exclusion Criteria:

  • Part II - Exclusion Criteria Patients with known hypersensitivity to bovine proteins.
  • Patient has undergone prior radiation therapy to the operative site (groin).
  • Patient is pregnant or lactating.
  • Patient is steroid dependent within last 6 months.
  • Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.
  • Patients with pre-existing lymphedema.
  • Patients with other pre-existing medical conditions as per the discretion of the principal investigator.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506311

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

Sponsors and Collaborators
M.D. Anderson Cancer Center
Bayer

Investigators
Principal Investigator:     Janice N. Cormier, MD     U.T.M.D. Anderson Cancer Center    
  More Information


Publications indexed to this study:

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Janice N. Cormier, MD/Associate Professor )
Study ID Numbers:   GS01-564
First Received:   July 23, 2007
Last Updated:   March 24, 2008
ClinicalTrials.gov Identifier:   NCT00506311
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Superficial Groin Dissection  
Melanoma  
Fibrin Tissue Adhesive  
Fibrin Sealant
Tisseel
Seroma

Study placed in the following topic categories:
Neuroectodermal Tumors
Fibrin Tissue Adhesive
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Coagulants
Therapeutic Uses
Hematologic Agents
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on October 10, 2008




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