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Sponsors and Collaborators: |
Oxford Radcliffe Hospitals NHS Trust Baxter Healthcare Corporation |
Information provided by: | Oxford Radcliffe Hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT00324272 |
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 |
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. |
Estimated Enrollment: | 80 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | December 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Contact: Henk P. Giele, MBBS FRACS | +44 (0) 1865 224 793 | henk.giele@orh.nhs.uk |
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 |
Oxford Radcliffe Hospitals NHS Trust |
Baxter Healthcare Corporation |
Principal Investigator: | Henk P. Giele, MBBS FRACS | UK: National Health Service |
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 |
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