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

Inclusion 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