Post-Operative Drainage Following Lymph Node Dissection

Phase 4

Completed

• Conditions: Malignant Melanoma; Carcinoma, Squamous Cell
• Interventions: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.

• Registration Number: NCT00324272
• Lead Sponsor: Oxford University Hospitals NHS Trust

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.

Study Timeline

• Study Start: 2003-01
• Status Verified: 2006-05
• Study First Submitted: 2006-05-08
• Study First Submitted QC: 2006-05-08
• Study First Posted: 2006-05-10
• Primary Completion: 2006-12
• Study Completion: 2010-06
• Results First Submitted: 2011-04-12
• Results First Submitted QC: 2011-07-18
• Last Update Submitted: 2011-07-18
• Results First Posted: 2011-08-11
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Groin dissection: no sealant used.	Fibrin Sealant (Tisseel) used in the Experimental Arm.	-
Axillary dissection: sealant used.	Fibrin Sealant (Tisseel) used in the Experimental Arm.	-
Axillary dissection: no sealant used.	Fibrin Sealant (Tisseel) used in the Experimental Arm.	-
Groin dissection: sealant used.	Fibrin Sealant (Tisseel) used in the Experimental Arm.	-

Primary Outcome Measures

Name	Time	Method
Post-operative Wound Drainage.	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 Outcome Measures

Name	Time	Method
Length of Hospital Inpatient Stay.	From date of surgery until date of discharge from hospital.	The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital.
Length of Time Drains Remain in Situ.	From date of surgery until date of wound drain removal.	The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain.
Number of Patients With Post-operative Complications (Excluding Lymphoedema).	Until wound healing complete.	Complications were classified as being either 'Minor' (i.e. (managed without operation, prolonged hospital stay or readmission) or 'Major' (i.e. requiring surgical intervention or readmission to hospital). The number of patients with each 'Minor' and 'Major' complication were recorded.
Post Operative Pain Score Measured on 1st Post-operative Day.	During the immediate post-operative period.	Pain score was recorded at 24 hours following the completion of surgery using a Visual Analogue Score (using a scale of 1 \[no pain\] to 10 \[very severe pain\]) which the patient was asked to record.
Disease Recurrence.	From date of surgery until end of study follow-up period (1st June 2010)	This was measured as either: 1. the number of participants with local recurrence; 2. the number of participants with in transit or regional recurrence; or 3. the number of participants with distant metastasis (but alive on 1st June 2010).
Death.	From day of surgery until end of study follow-up period (1st June 2010)	Death was recorded as the number of participants who had died by the end of the study follow-up period (1st June 2010). Deaths were recorded as either being related to the primary disease (i.e. due to distant metastasis) or death due to another (unrelated) cause (e.g. myocardial infarction or cerebrovascular accident).