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| Sponsored by: |
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:
| Condition | Intervention |
|
Melanoma |
Drug: Fibrin Sealant |
| MedlinePlus related topics: | Cancer Melanoma |
| ChemIDplus related topics: | Fibrin Beriplast |
| 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 |
| Estimated Enrollment: | 115 |
| Study Start Date: | May 2002 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Fibrin Sealant
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Drug: Fibrin Sealant
Tisseel applied externally to the dissected axillary area.
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2: No Intervention
No Fibrin Sealant.
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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 Cancer Center.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |||||
| U.T.M.D. Anderson Cancer Center | |||||
| Houston, Texas, United States, 77030 | |||||
| M.D. Anderson Cancer Center |
| Principal Investigator: | Paul F. Mansfield, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Paul F. Mansfield, MD/Professor ) |
| Study ID Numbers: | GS01-565 |
| First Received: | July 19, 2007 |
| Last Updated: | March 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00504582 |
| Health Authority: | United States: Institutional Review Board |
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