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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

Phase 3
18 Years
Not Enrolling
Lymphedema, Perioperative/Postoperative Complications, Vulvar Cancer

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Trial Information

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


- 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.

Inclusion Criteria


- 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



- Over 18

Performance status:

- GOG 0-3

Life expectancy:

- Not specified


- Platelet count at least 100,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- No bleeding disorder


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Albumin at least 3.0 g/dL


- Creatinine no greater than 2.0 mg/dL


- No prior lower extremity deep vein thrombosis


- 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


Biologic therapy:

- Not specified


- No prior chemotherapy for a prior malignancy

- Concurrent adjuvant chemotherapy allowed

Endocrine therapy:

- Not specified


- No prior radiotherapy for a prior malignancy

- No prior radiotherapy to pelvis, abdomen, inguinal area, or lower extremity


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively

Principal Investigator

Jay W. Carlson, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology of West Michigan


United States: Federal Government

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Lymphedema
  • Perioperative/Postoperative Complications
  • Vulvar Cancer
  • lymphedema
  • perioperative/postoperative complications
  • stage I vulvar cancer
  • stage II vulvar cancer
  • stage III vulvar cancer
  • stage IVB vulvar cancer
  • Lymphedema
  • Postoperative Complications
  • Vulvar Neoplasms



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