Clinical trial · Interventional
Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
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
NCT00028951CI-TRIAL-00011237completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fibrin sealant | Drug | — | UNRESOLVED |
| surgical wound closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively
Secondary outcomes (1)
- measure
- Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTCarlson JW, Kauderer J, Walker JL, Gold MA, O'Malley D, Tuller E, Clarke-Pearson DL; Gynecologic Oncology Group. A randomized phase III trial of VH fibrin sealant to reduce lymphedema after inguinal lymph node dissection: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Jul;110(1):76-82. doi: 10.1016/j.ygyno.2008.03.005. Epub 2008 May 15. PMID 18482765
- RESULTCarlson J, Kauderer J, Walker J, et al.: Phase III trial of Tisseel to reduce lymphedema after inguinal lymph node dissection: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-228, 2007.