At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 74 enrolled

Drug / intervention

Fibrin Sealant (Tisseel) used in the Experimental Arm.drug

Likely dose

Fibrin Sealant (Tisseel) used in the Experimental Arm. 4 mlfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00324272

NCT00324272Phase 4Completed

Compare CT.gov

Can Fibrin Sealant be Used to Reduce Post-operative Drainage Following Lymph Node Dissection: a Prospective Randomised Double Blind Trial.

Oxford University Hospitals NHS Trust·interventional·Posted May 10, 2006·Updated Aug 11, 2011

In Brief

A Phase 4 clinical trial evaluating Fibrin Sealant (Tisseel) used in the Experimental Arm. for Malignant Melanoma and Carcinoma, Squamous Cell. Completed, enrolled 74 participants.

Detailed Summary

The purpose of this study is to determine whether the use of fibrin sealant reduces post-operative drainage following groin and axillary lymph node dissection.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMalignant Melanoma, Carcinoma, Squamous Cell

Countries--

CollaboratorsBaxter Healthcare Corporation

Timeline

Phase 4CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2003

First PostedMay 2006

Primary CompletionDec 2006

Study CompletionJun 2010

TodayJul 2026

First PostedMay 10, 2006

Enrollment StartJan 1, 2003

Primary CompletionDec 1, 2006

Study CompletionJun 1, 2010

TodayJul 2, 2026

Enrollment to primary: 3.9 yearsPosted 20.1 years ago

Interventions

Fibrin Sealant (Tisseel) used in the Experimental Arm.drug

For patients in the Experimental (Treatment) Arm, 4 ml of Tisseel fibrin sealant were instilled into the wound using the Duploject™ spray delivery system prior to wound closure. Tisseel™ fibrin sealant was provided by Baxter Healthcare Ltd., Newbury, Berkshire, UK. For patients in the Active Comparator (Control) Arm, no fibrin sealant was used during wound closure (with the surgical procedure being identical in all other respects).