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

NCT00028951 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-07-09

No results posted yet for this study

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.

Conditions

  • Lymphedema
  • Perioperative/Postoperative Complications
  • Vulvar Cancer

Interventions

DRUG

fibrin sealant

PROCEDURE

surgical wound closure

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gynecologic Oncology Group

    lead NETWORK

Principal Investigators

  • Jay W. Carlson, DO · Gynecologic Oncology of West Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2005-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00028951 on ClinicalTrials.gov