Post-Operative Drainage Following Lymph Node Dissection

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00324272
First received: May 8, 2006
Last updated: July 18, 2011
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Carcinoma, Squamous Cell
Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Fibrin Sealant be Used to Reduce Post-operative Drainage Following Lymph Node Dissection: a Prospective Randomised Double Blind Trial.

Resource links provided by NLM:


Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • Post-operative Wound Drainage. [ Time Frame: From date of surgery to date of wound drain removal (typically a period of approximately one week). ] [ Designated as safety issue: No ]
    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. [ Time Frame: From date of surgery until date of discharge from hospital. ] [ Designated as safety issue: No ]
    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. [ Time Frame: From date of surgery until date of wound drain removal. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Until wound healing complete. ] [ Designated as safety issue: No ]
    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. [ Time Frame: During the immediate post-operative period. ] [ Designated as safety issue: No ]
    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. [ Time Frame: From date of surgery until end of study follow-up period (1st June 2010) ] [ Designated as safety issue: No ]
    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. [ Time Frame: From day of surgery until end of study follow-up period (1st June 2010) ] [ Designated as safety issue: No ]
    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).


Enrollment: 74
Study Start Date: January 2003
Study Completion Date: June 2010
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Groin dissection: sealant used. 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).

Active Comparator: Groin dissection: no sealant used. 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).

Experimental: Axillary dissection: sealant used. 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).

Active Comparator: Axillary dissection: no sealant used. 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).


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324272

Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Baxter Healthcare Corporation
Investigators
Principal Investigator: Henk P. Giele, MBBS FRACS UK: National Health Service
  More Information

Publications:
Responsible Party: Mr. H. Giele, Consultant Plastic & Reconstructive Surgeon, Oxford Radcliffe Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00324272     History of Changes
Other Study ID Numbers: C02.240
Study First Received: May 8, 2006
Results First Received: April 12, 2011
Last Updated: July 18, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Oxford University Hospitals NHS Trust:
Groin dissection
Axilla (or axillary) dissection
Lymph node dissection
Lymphadenectomy
Seroma
Wound drainage
Fibrin sealant
Malignant melanoma
Squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Melanoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014