Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients
NCT ID: NCT00506311
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2003-02-28
2008-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fibrin Sealant
Fibrin Sealant
Tisseel applied externally to the dissected groin area.
No Fibrin Sealant
No interventions assigned to this group
Interventions
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Fibrin Sealant
Tisseel applied externally to the dissected groin area.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with melanoma for which a superficial node dissection is indicated (with or without a concurrent deep (ilioinguinal) node dissection.
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Bayer
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Janice N. Cormier, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Related Links
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UT MD Anderson Cancer Center
Other Identifiers
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GS01-564
Identifier Type: -
Identifier Source: org_study_id