Post-Operative Drainage Following Lymph Node Dissection

July 18, 2011 updated by: Oxford University Hospitals NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Wound Drainage.
Time Frame: From date of surgery to date of wound drain removal (typically a period of approximately one week).
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Inpatient Stay.
Time Frame: From date of surgery until date of discharge from hospital.
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.
Length of Time Drains Remain in Situ.
Time Frame: From date of surgery until date of wound drain removal.
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.
Number of Patients With Post-operative Complications (Excluding Lymphoedema).
Time Frame: Until wound healing complete.
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.
Post Operative Pain Score Measured on 1st Post-operative Day.
Time Frame: During the immediate post-operative period.
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.
Disease Recurrence.
Time Frame: From date of surgery until end of study follow-up period (1st June 2010)
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)
Death.
Time Frame: From day of surgery until end of study follow-up period (1st June 2010)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Hospitals NHS Trust

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Henk P. Giele, MBBS FRACS, UK: National Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Estimate)

August 11, 2011

Last Update Submitted That Met QC Criteria

July 18, 2011

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C02.240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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