Skip to main content
OpenTrials
Completed

NCT Number: NCT00324272

Post-Operative Drainage Following Lymph Node Dissection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Melanoma Carcinoma Carcinoma, Squamous Cell Inflammation Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Seroma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibrin Sealant (Tisseel) used in the Experimental Arm.

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2010
First posted
May 10, 2006
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.