Clinical trial NCT00324272: Post-Operative Drainage Following Lymph Node Dissection
Official title: Can Fibrin Sealant be Used to Reduce Post-operative Drainage Following Lymph Node Dissection: a Prospective Randomised Double Blind Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malignant Melanoma
Carcinoma, Squamous Cell
Keywords: Groin dissection
Axilla (or axillary) dissection
Lymph node dissection
Lymphadenectomy
Seroma
Wound drainage
Fibrin sealant
Malignant melanoma
Squamous cell carcinoma
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2006-05-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative Wound Drainage.
timeFrame: From date of surgery to date of wound drain removal (typically a period of approximately one week).
Secondary outcomes:
measure: Length of Hospital Inpatient Stay.
timeFrame: From date of surgery until date of discharge from hospital.
measure: Length of Time Drains Remain in Situ.
timeFrame: From date of surgery until date of wound drain removal.
measure: Number of Patients With Post-operative Complications (Excluding Lymphoedema).
timeFrame: Until wound healing complete.
measure: Post Operative Pain Score Measured on 1st Post-operative Day.
timeFrame: During the immediate post-operative period.
measure: Disease Recurrence.
timeFrame: From date of surgery until end of study follow-up period (1st June 2010)
measure: Death.
timeFrame: From day of surgery until end of study follow-up period (1st June 2010)
Other outcomes:
Locations:
Study officials:
affiliation: UK: National Health Service
name: Henk P. Giele, MBBS FRACS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/00006534-200112000-00044.
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.
citation: 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. doi: 10.1023/a:1010671209279.
citation: 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. doi: 10.1007/s100160010049. Epub 2001 Mar 1.
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. doi: 10.1002/bjs.4435.
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. Epub 2011 Apr 1.