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Post-Operative Drainage Following Lymph Node Dissection

NCT00324272 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2011-08-11

Study results available
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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.

Conditions

  • Malignant Melanoma
  • Carcinoma, Squamous Cell

Interventions

DRUG

Fibrin Sealant (Tisseel) used in the Experimental Arm.

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).

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Henk P. Giele, MBBS FRACS · UK: National Health Service

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2006-12-31
Completion
2010-06-30

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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 NCT00324272 on ClinicalTrials.gov