A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma
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
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
From surgery to 30 days post surgery
Janice N. Cormier, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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