NCT00324272

Post-Operative Drainage Following Lymph Node Dissection

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Oxford University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Malignant Melanoma
• Carcinoma, Squamous Cell

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-12-01
• Completion: 2010-06-01
• First posted: 2006-05-10
• Last updated: 2011-08-11
• Results posted: 2011-08-11