Post-Operative Drainage Following Lymph Node Dissection

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324272
• Other study ID #: C02.240
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2006
• Last updated: July 18, 2011
• Start date: January 2003
• Est. completion date: June 2010

Study information

• Verified date: May 2006
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 2010
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Malignant Melanoma
• Melanoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	Baxter Healthcare Corporation

References & Publications (6)

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. — View Citation

Giovannacci L, Renggli JC, Eugster T, Stierli P, Hess P, Gürke 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1002/bjs.7462. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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)	No
Secondary	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)	No