Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Lymphedema, Perioperative/Postoperative Complications, Vulvar Cancer

Intervention / Treatment
-----------------
* Drug: fibrin sealant
* Procedure: surgical wound closure


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of vulvar malignancy Stage I-IVB Planned radical vulvectomy or hemivulvectomy AND Ipsilateral or bilateral inguinal lymphadenectomy Presence of groin node metastases is allowed No primary or secondary lymphedema of the lower extremities PATIENT CHARACTERISTICS: Age: Over 18 Performance status: GOG 0-3 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 No bleeding disorder Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Albumin at least 3.0 g/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No prior lower extremity deep vein thrombosis Other: No known sensitivity or anaphylaxis to bovine-derived products No known prior exposure to fibrin tissue adhesive No other malignancy within the past 5 years except nonmelanoma skin cancer No nonhealing ulcer or chronic infection of the lower extremity, including superficial phlebitis No prior fracture of any portion of either leg Preoperative circumferential measurements of legs must differ by less than 3 cm Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for a prior malignancy Concurrent adjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for a prior malignancy No prior radiotherapy to pelvis, abdomen, inguinal area, or lower extremity Surgery: See Disease Characteristics No prior inguinal surgery No prior surgery to veins or arteries of either leg No other concurrent elective surgery during same operative event as inguinal lymphadenectomy Other: At least 30 days since prior investigational products or devices At least 7 days since prior anticoagulants Concurrent enrollment on GOG-0173 or other adjuvant treatment protocols is allowed No other concurrent investigational products or devices

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fibrin sealant|nan|
|Procedure: surgical wound closure|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I vulvar cancer, lymphedema, perioperative/postoperative complications, stage II vulvar cancer, stage III vulvar cancer, stage IVB vulvar cancer