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

Phase 4
18 Years
Not Enrolling
Malignant Melanoma, Carcinoma, Squamous Cell

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Post-operative Wound Drainage.

Outcome Description:

The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.

Outcome Time Frame:

From date of surgery to date of wound drain removal (typically a period of approximately one week).

Safety Issue:


Principal Investigator

Henk P. Giele, MBBS FRACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UK: National Health Service


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

January 2003

Completion Date:

June 2010

Related Keywords:

  • Malignant Melanoma
  • Carcinoma, Squamous Cell
  • Groin dissection
  • Axilla (or axillary) dissection
  • Lymph node dissection
  • Lymphadenectomy
  • Seroma
  • Wound drainage
  • Fibrin sealant
  • Malignant melanoma
  • Squamous cell carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Melanoma