Lymphedema Clinical Trial
Official title:
A Phase III Clinical Trial Use of TISSEEL VH Fibrin Sealant to Reduce Lymphedema Incidence After Inguinal Lymph Node Dissection Performed in the Management of Vulvar Malignancies
RATIONALE: Fibrin sealant may decrease lymphedema following surgery to remove lymph nodes in
the groin by helping to seal the lymphatic vessels. It is not yet known if fibrin sealant is
effective in decreasing lymphedema following surgery to remove lymph nodes.
PURPOSE: Randomized phase III trial to determine the effectiveness of fibrin sealant in
reducing lymphedema following surgical removal of lymph nodes in patients who have cancer of
the vulva.
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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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