Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Gynecologic Oncology Group
With
OBJECTIVES: * Compare the incidence of lymphedema of the lower extremity after lymph node dissection in patients with vulvar malignancies treated with fibrin sealant vs standard care. * Compare the frequency of surgical complications in patients treated with fibrin sealant vs standard care. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: After radical vulvectomy or hemivulvectomy and lymphadenectomy, patients receive fibrin sealant to surgical site. * Arm II: After surgery, patients receive standard care for closure of surgical site. Lymphedema is assessed at time of drain removal, at week 6, and then at months 3 and 6. Patients are followed at week 6 and at months 3 and 6. PROJECTED ACCRUAL: A total of 120-130 patients (60-65 per treatment arm) will be accrued for this study within 2 years.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
