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Post-Operative Drainage Following Lymph Node Dissection

Primary Purpose

Malignant Melanoma, Carcinoma, Squamous Cell

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fibrin Sealant (Tisseel) used in the Experimental Arm.
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring Groin dissection, Axilla (or axillary) dissection, Lymph node dissection, Lymphadenectomy, Seroma, Wound drainage, Fibrin sealant, Malignant melanoma, Squamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Groin dissection: sealant used.

    Groin dissection: no sealant used.

    Axillary dissection: sealant used.

    Axillary dissection: no sealant used.

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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).
    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).

    Full Information

    First Posted
    May 8, 2006
    Last Updated
    July 18, 2011
    Sponsor
    Oxford University Hospitals NHS Trust
    Collaborators
    Baxter Healthcare Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00324272
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Oxford University Hospitals NHS Trust
    Collaborators
    Baxter Healthcare Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Groin dissection: sealant used.
    Arm Type
    Experimental
    Arm Title
    Groin dissection: no sealant used.
    Arm Type
    Active Comparator
    Arm Title
    Axillary dissection: sealant used.
    Arm Type
    Experimental
    Arm Title
    Axillary dissection: no sealant used.
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Fibrin Sealant (Tisseel) used in the Experimental Arm.
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Post-operative Wound Drainage.
    Description
    The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.
    Time Frame
    From date of surgery to date of wound drain removal (typically a period of approximately one week).
    Secondary Outcome Measure Information:
    Title
    Length of Hospital Inpatient Stay.
    Description
    The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital.
    Time Frame
    From date of surgery until date of discharge from hospital.
    Title
    Length of Time Drains Remain in Situ.
    Description
    The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain.
    Time Frame
    From date of surgery until date of wound drain removal.
    Title
    Number of Patients With Post-operative Complications (Excluding Lymphoedema).
    Description
    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.
    Time Frame
    Until wound healing complete.
    Title
    Post Operative Pain Score Measured on 1st Post-operative Day.
    Description
    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.
    Time Frame
    During the immediate post-operative period.
    Title
    Disease Recurrence.
    Description
    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).
    Time Frame
    From date of surgery until end of study follow-up period (1st June 2010)
    Title
    Death.
    Description
    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).
    Time Frame
    From day of surgery until end of study follow-up period (1st June 2010)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Henk P. Giele, MBBS FRACS
    Organizational Affiliation
    UK: National Health Service
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11743409
    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.
    Results Reference
    background
    PubMed Identifier
    8985079
    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.
    Results Reference
    background
    PubMed Identifier
    11518470
    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.
    Results Reference
    background
    PubMed Identifier
    11265082
    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.
    Results Reference
    background
    PubMed Identifier
    14716794
    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.
    Results Reference
    background
    PubMed Identifier
    21456091
    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.
    Results Reference
    result

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    Post-Operative Drainage Following Lymph Node Dissection

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