Post-Operative Drainage Following Lymph Node Dissection

• Length of Hospital Inpatient Stay. [ Time Frame: From date of surgery until date of discharge from hospital. ] [ Designated as safety issue: No ]
  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. [ Time Frame: From date of surgery until date of wound drain removal. ] [ Designated as safety issue: No ]
  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). [ Time Frame: Until wound healing complete. ] [ Designated as safety issue: No ]
  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. [ Time Frame: During the immediate post-operative period. ] [ Designated as safety issue: No ]
  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. [ Time Frame: From date of surgery until end of study follow-up period (1st June 2010) ] [ Designated as safety issue: No ]
  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. [ Time Frame: From day of surgery until end of study follow-up period (1st June 2010) ] [ Designated as safety issue: No ]
  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).

• Length of hospital stay
• Length of time drains remain in situ
• Post-operative complication rate
• Post-operative pain

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.

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.

• Malignant Melanoma
• Carcinoma, Squamous Cell

• Experimental: Groin dissection: sealant used.
  Intervention: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.
• Active Comparator: Groin dissection: no sealant used.
  Intervention: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.
• Experimental: Axillary dissection: sealant used.
  Intervention: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.
• Active Comparator: Axillary dissection: no sealant used.
  Intervention: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.

• Swan MC, Oliver DW, Cassell OC, Coleman DJ, Williams N, Morritt DG, Giele HP. Randomized controlled trial of fibrin sealant to reduce postoperative drainage following elective lymph node dissection. Br J Surg. 2011 Jul;98(7):918-24. Epub 2011 Apr 1.
• Oliver DW, Hamilton SA, Figle AA, Wood SH, Lamberty BG. A prospective, randomized, double-blind trial of the use of fibrin sealant for face lifts. Plast Reconstr Surg. 2001 Dec;108(7):2101-5, discussion 2106-7.
• Moore MM, Nguyen DH, Spotnitz WD. Fibrin sealant reduces serous drainage and allows for earlier drain removal after axillary dissection: a randomized prospective trial. Am Surg. 1997 Jan;63(1):97-102.
• Berger A, Tempfer C, Hartmann B, Kornprat P, Rossmann A, Neuwirth G, Tulusan A, Kubista E. Sealing of postoperative axillary leakage after axillary lymphadenectomy using a fibrin glue coated collagen patch: a prospective randomised study. Breast Cancer Res Treat. 2001 May;67(1):9-14.
• Giovannacci L, Renggli JC, Eugster T, Stierli P, Hess P, Gurke L. Reduction of groin lymphatic complications by application of fibrin glue: preliminary results of a randomized study. Ann Vasc Surg. 2001 Mar;15(2):182-5. Epub 2001 Mar 1.
• Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60.

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.