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Post-Operative Drainage Following Lymph Node Dissection

This study is currently recruiting participants.
Verified by Oxford Radcliffe Hospitals NHS Trust, May 2006

Sponsors and Collaborators: Oxford Radcliffe Hospitals NHS Trust
Baxter Healthcare Corporation
Information provided by: Oxford Radcliffe Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00324272
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Carcinoma, Squamous Cell
Drug: Fibrin Sealant (Tisseel)
Phase IV

MedlinePlus related topics:   Melanoma   

ChemIDplus related topics:   Fibrin    Beriplast   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Can Fibrin Sealant Be Used to Reduce Post-Operative Drainage Following Lymph Node Dissection: a Prospective Randomised Double Blind Trial.

Further study details as provided by Oxford Radcliffe Hospitals NHS Trust:

Primary Outcome Measures:
  • Post-operative wound drainage.

Secondary Outcome Measures:
  • Length of hospital stay
  • Length of time drains remain in situ
  • Post-operative complication rate
  • Post-operative pain

Estimated Enrollment:   80
Study Start Date:   January 2003
Estimated Study Completion Date:   December 2006

Detailed Description:

Background: Fibrin sealant has been used for many years in clinical practice and has a wide range of applications including the control of lymphatic leaks and haemostasis. The physiological mechanism of action of fibrin was first described by Morawitz in 1905; fibrin sealant was first marketed in 1983.

Lymph node dissection is undertaken for the control of malignant disease - frequently malignant melanoma or squamous cell carcinoma. Following groin or axillary dissection, excessive post operative drainage may necessitate the presence of wound drains for 10 days or more. This may prolong hospital stay in some patients, and may be associated with an increased complication rate (such as wound infection).

Hypothesis: the use of fibrin sealant prior to wound closure following either groin or axillary dissection may reduce post-operative wound drainage.

Comparison: patients who require an elective groin or axillary dissection who either undergo standard wound closure or those who have fibrin sealant instilled into the surgical wound prior to wound closure.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Patients over 18 years of age requiring groin or axillary lymph node dissection for malignant disease.

Exclusion Criteria:

Patients under age 18 years. Patients unable to speak English. Patients with learning difficulties. Patients with mental illness. Prisoners. Other vulnerable groups.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324272

Contacts
Contact: Henk P. Giele, MBBS FRACS     +44 (0) 1865 224 793     henk.giele@orh.nhs.uk    

Locations
United Kingdom, Oxfordshire
Department of Plastic & Reconstructive Surgery, Radcliffe Infirmary     Recruiting
      Oxford, Oxfordshire, United Kingdom, OX2 6HE
      Contact: Henk P. Giele, MBBS FRACS     +44 (0) 1865 224 793     henk.giele@orh.nhs.uk    
      Contact: Marc C. Swan, MBBS MRCS     +44 (0) 1865 224 818     marc.swan@nds.ox.ac.uk    

Sponsors and Collaborators
Oxford Radcliffe Hospitals NHS Trust
Baxter Healthcare Corporation

Investigators
Principal Investigator:     Henk P. Giele, MBBS FRACS     UK: National Health Service    
  More Information


Publications:

Study ID Numbers:   C02.240
First Received:   May 8, 2006
Last Updated:   May 8, 2006
ClinicalTrials.gov Identifier:   NCT00324272
Health Authority:   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Oxford Radcliffe Hospitals NHS Trust:
Groin dissection  
Axilla (or axillary) dissection  
Lymph node dissection  
Lymphadenectomy  
Seroma  
Wound drainage
Fibrin sealant
Malignant melanoma
Squamous cell carcinoma

Study placed in the following topic categories:
Fibrin Tissue Adhesive
Squamous cell carcinoma
Melanoma
Carcinoma
Neuroendocrine Tumors
Epidermoid carcinoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Carcinoma, squamous cell
Neuroepithelioma
Neoplasms, Squamous Cell
Nevus
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Coagulants
Therapeutic Uses
Hematologic Agents
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on October 03, 2008




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