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

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.

Timeline

Start

2003-01

Primary completion

2005-12

Completion

—

Publications

• Results Carlson 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.
• Results Carlson 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.

Drugs

Indications