Can Fibrin Sealant be Used to Reduce Post-operative Drainage Following Lymph Node Dissection: a Prospective Randomised Double Blind Trial.
Overview
- Phase
- Phase 4
- Intervention
- Fibrin Sealant (Tisseel) used in the Experimental Arm.
- Conditions
- Malignant Melanoma
- Sponsor
- Oxford University Hospitals NHS Trust
- Enrollment
- 74
- Primary Endpoint
- Post-operative Wound Drainage.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
Eligibility 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.
Arms & Interventions
Groin dissection: sealant used.
Intervention: Fibrin Sealant (Tisseel) used in the Experimental Arm.
Groin dissection: no sealant used.
Intervention: Fibrin Sealant (Tisseel) used in the Experimental Arm.
Axillary dissection: sealant used.
Intervention: Fibrin Sealant (Tisseel) used in the Experimental Arm.
Axillary dissection: no sealant used.
Intervention: Fibrin Sealant (Tisseel) used in the Experimental Arm.
Outcomes
Primary Outcomes
Post-operative Wound Drainage.
Time Frame: From date of surgery to date of wound drain removal (typically a period of approximately one week).
The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.
Secondary Outcomes
- Length of Hospital Inpatient Stay.(From date of surgery until date of discharge from hospital.)
- Length of Time Drains Remain in Situ.(From date of surgery until date of wound drain removal.)
- Number of Patients With Post-operative Complications (Excluding Lymphoedema).(Until wound healing complete.)
- Post Operative Pain Score Measured on 1st Post-operative Day.(During the immediate post-operative period.)
- Disease Recurrence.(From date of surgery until end of study follow-up period (1st June 2010))
- Death.(From day of surgery until end of study follow-up period (1st June 2010))