Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324272
Status:
COMPLETED
Last Update Posted:
2011-08-11
First Post:
2006-05-08
Brief Title:
Post-Operative Drainage Following Lymph Node Dissection
Sponsor:
Oxford University Hospitals NHS Trust
Organization:
Oxford University Hospitals NHS Trust
Study Overview
Official Title:
Can Fibrin Sealant be Used to Reduce Post-operative Drainage Following Lymph Node Dissection a Prospective Randomised Double Blind Trial
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None