Post-Operative Drainage Following Lymph Node Dissection

NHS Trust

Status and phase: Completed; Phase 4

Conditions: Carcinoma, Squamous Cell; Malignant Melanoma

Treatments: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00324272

C02.240

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 4 patient groups

Groin dissection: sealant used.

Experimental group

Treatment:

Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.

Groin dissection: no sealant used.

Active Comparator group

Treatment:

Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.

Axillary dissection: sealant used.

Experimental group

Treatment:

Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.

Axillary dissection: no sealant used.

Active Comparator group

Treatment:

Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.