Title
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.
Phase
Phase 4Lead Sponsor
University of OxfordStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Malignant Melanoma Carcinoma, Squamous CellIntervention/Treatment
human fibrin ...Study Participants
74The purpose of this study is to determine whether the use of fibrin sealant reduces post-operative drainage following groin and axillary lymph node dissection.
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.
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).
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.
| Event Type | Organ System | Event Term | Groin Dissection: Sealant Used. | Groin Dissection: no Sealant Used. | Axillary Dissection: Sealant Used. | Axillary Dissection: no Sealant Used. |
|---|
The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.
The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital.
The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain.
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.
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.
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 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).
