Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
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|ClinicalTrials.gov Identifier: NCT00028951|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 9, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphedema Perioperative/Postoperative Complications Vulvar Cancer||Drug: fibrin sealant Procedure: surgical wound closure||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||December 2005|
- Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively
- Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively
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): NCT00028951
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|Study Chair:||Jay W. Carlson, DO||Gynecologic Oncology of West Michigan|