Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients
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|ClinicalTrials.gov Identifier: NCT00506311|
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : August 2, 2012
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.
- To determine the postoperative morbidity rate using fibrin sealant following superficial groin 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 or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Fibrin Sealant||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||March 2008|
|Experimental: Fibrin Sealant||
Drug: Fibrin Sealant
Tisseel applied externally to the dissected groin area.
Other Name: Tisseel
|No Intervention: No Fibrin Sealant|
- Time-to-Drain Removal [ Time Frame: From surgery to 30 days post surgery ]The superficial groin drain will be removed once cumulative serous drainage volume 30 ml / 24 hours for 2 days or maximum of = or < 30 days has elapsed since surgery. Time calculated as days from installation of drain at first day of surgery to removal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506311
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Janice N. Cormier, MD||M.D. Anderson Cancer Center|