Post-Operative Drainage Following Lymph Node Dissection

Study 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.

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

Conditions
-----------------
Malignant Melanoma, Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Groin dissection: sealant used.<br> | Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.<br>* 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).<br>|
| Active Comparator: Groin dissection: no sealant used.<br> | Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.<br>* 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).<br>|
| Experimental: Axillary dissection: sealant used.<br> | Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.<br>* 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).<br>|
| Active Comparator: Axillary dissection: no sealant used.<br> | Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Wound Drainage. | The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain. | From date of surgery to date of wound drain removal (typically a period of approximately one week). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Inpatient Stay. | The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital. | From date of surgery until date of discharge from hospital. | 
| Length of Time Drains Remain in Situ. | The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain. | From date of surgery until date of wound drain removal. | 
| Number of Patients With Post-operative Complications (Excluding Lymphoedema). | 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. | Until wound healing complete. | 
| Post Operative Pain Score Measured on 1st Post-operative Day. | 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. | During the immediate post-operative period. | 
| Disease Recurrence. | 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). | From date of surgery until end of study follow-up period (1st June 2010) | 
| Death. | 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). | From day of surgery until end of study follow-up period (1st June 2010) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Groin dissection, Axilla (or axillary) dissection, Lymph node dissection, Lymphadenectomy, Seroma, Wound drainage, Fibrin sealant, Malignant melanoma, Squamous cell carcinoma