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
Results First Received: April 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Malignant Melanoma
Carcinoma, Squamous Cell
Intervention: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient recruitment occurred between 1.1.2003 and 31.12.2006. A total of 74 patients were recruited. All patients were followed up until 1.6.2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 74 patients who were enrolled in the trial were followed up until 1.6.10 (unless they died prior to this date).

Reporting Groups
  Description
Groin Dissection: Sealant Used. All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
Groin Dissection: no Sealant Used. All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
Axillary Dissection: Sealant Used. A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
Axillary Dissection: no Sealant Used. A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.

Participant Flow:   Overall Study
    Groin Dissection: Sealant Used.     Groin Dissection: no Sealant Used.     Axillary Dissection: Sealant Used.     Axillary Dissection: no Sealant Used.  
STARTED     18     20     18     18  
COMPLETED     18     20     18     18  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Groin Dissection: Sealant Used. All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
Groin Dissection: no Sealant Used. All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
Axillary Dissection: Sealant Used. A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
Axillary Dissection: no Sealant Used. A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
Total Total of all reporting groups

Baseline Measures
    Groin Dissection: Sealant Used.     Groin Dissection: no Sealant Used.     Axillary Dissection: Sealant Used.     Axillary Dissection: no Sealant Used.     Total  
Number of Participants  
[units: participants]
  18     20     18     18     74  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     12     13     10     16     51  
>=65 years     6     7     8     2     23  
Age  
[units: years]
Mean ± Standard Deviation
  57.3  ± 17.9     58.2  ± 18.1     64.7  ± 18.4     57.3  ± 14.2     58.1  ± 17.1  
Gender  
[units: participants]
         
Female     9     13     7     6     35  
Male     9     7     11     12     39  
Region of Enrollment  
[units: participants]
         
United Kingdom     18     20     18     18     74  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Post-operative Wound Drainage.   [ Time Frame: From date of surgery to date of wound drain removal (typically a period of approximately one week). ]

2.  Secondary:   Length of Hospital Inpatient Stay.   [ Time Frame: From date of surgery until date of discharge from hospital. ]

3.  Secondary:   Length of Time Drains Remain in Situ.   [ Time Frame: From date of surgery until date of wound drain removal. ]

4.  Secondary:   Number of Patients With Post-operative Complications (Excluding Lymphoedema).   [ Time Frame: Until wound healing complete. ]

5.  Secondary:   Post Operative Pain Score Measured on 1st Post-operative Day.   [ Time Frame: During the immediate post-operative period. ]

6.  Secondary:   Disease Recurrence.   [ Time Frame: From date of surgery until end of study follow-up period (1st June 2010) ]

7.  Secondary:   Death.   [ Time Frame: From day of surgery until end of study follow-up period (1st June 2010) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mr. Henk Giele, Consultant Plastic & Reconstructive Surgeon
Organization: John Radcliffe Hospital
phone: 01865 231 056
e-mail: henk.giele@orh.nhs.uk


Publications of Results:
Other 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