Timing of Postoperative Drain Removal Following Parotidectomy - a Prospective Randomized Controlled Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of British Columbia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01399021
First received: July 19, 2011
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

There is no standard of care of management following parotidectomies. Most practitioners however place a drain (usually a flat Davol closed suction drain/ Hemovac in the investigators institutions) in the wound bed at the end of the procedure, which is usually removed the day following the surgery, or when the drain output reaches a subjective number (depending on surgeon preference). The investigators hypothesis is that there is no difference in hematoma/bleeding or infection rate when post parotidectomy drains are removed in the recovery area on the day of the surgery prior to discharge, compared to drains that are kept in place for at least 1 day or until drainage is less than 50 cc/24 hrs. The investigators would therefore like to undergo a randomized control clinical trial to assess the rate of significant hematoma formation and infection, the need for readmission and length of admission secondary to these complications when comparing 2 groups: one where drains are removed prior to discharge from the recovery area and the other where the patients are discharged with the drain and seen the next post operative day in the office. The drain output will then be measured and the drain taken out.


Condition Intervention
Parotidectomy
Other: Early Drain Removal
Other: Late Drain Removal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Timing of Postoperative Drain Removal Following Parotidectomy and Its Effects on Hematoma and Infection Rate and Length of Hospital Stay- a Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Rate of hematoma formation [ Time Frame: Hematoma formed within 30 days after the surgery ] [ Designated as safety issue: No ]
    The proportions of hematoma formation in patients with early drain removal compared to later drain removal will be assessed


Secondary Outcome Measures:
  • Rate of infection [ Time Frame: Within 30 days following surgery ] [ Designated as safety issue: No ]
    The proportion of patients having a surgical wound infection in the group with early drain removal will be compared to that in later drain removal


Estimated Enrollment: 400
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Flat Davol drain
both arms will have flat davol drains placed at the end of the parotidectomy surgery
Other: Early Drain Removal
Drain will be removed prior to patient's discharge on the day of the surgery
Other: Late Drain Removal
Patient will be seen on the day following the surgery to have the drain removed

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years old
  • Competent
  • Patients undertaking unilateral or bilateral parotidectomies at Vancouver General Hospital, Vancouver; St. Paul's Hospital, Vancouver; or Surrey Memorial Hospital, Surrey.

Exclusion Criteria:

  • Patients on anticoagulation therapy
  • Patients classified in the preanesthetic evaluation as ASA ≥ 3, where a patient would require post operative overnight admission secondary to his comorbidities
  • Immunosuppression such as concurrent radiation or chemotherapy or receiving high dose corticosteroids
  • Concommitant infections requiring antibiotics
  • Patients who are having additional head and neck procedures at the time of the parotidectomy, other than skin excision (eg. Modified neck dissection, mandibulectomy, external auditory canal resection)
  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: NCT01399021

Contacts
Contact: Veronique Wan Fook Cheung, MDCM 604-992-7752 veroniquewan@gmail.com
Contact: Donald W Anderson, MD 604-941-9191 dwa@shaw.ca

Locations
Canada, British Columbia
Eagle Ridge Hospital Not yet recruiting
Port Moody, British Columbia, Canada
Principal Investigator: Donald W Anderson, MD         
Surrey Memorial Hospital Not yet recruiting
Surrey, British Columbia, Canada
Principal Investigator: Donald W Anderson, MD         
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Veronique Wan Fook Cheung, MDCM       veroniquewan@gmail.com   
Contact: Donald W Anderson, MD    604-941-9191    dwa@shaw.ca   
Principal Investigator: Donald W Anderson, MD         
St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Veronique Wan Fook Cheung, MDCM       veroniquewan@gmail.com   
Contact: Donald W Anderson, MD    604-941-9191    dwa@shaw.ca   
Principal Investigator: Donald W Anderson, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Donald W Anderson, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Donald W. Anderson, University of Brtish Columbia - Vancouver Coastal Health Research Institute
ClinicalTrials.gov Identifier: NCT01399021     History of Changes
Other Study ID Numbers: H11-01434
Study First Received: July 19, 2011
Last Updated: July 20, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Parotidectomy
Drain removal
Timing
Hematoma
Surgical wound infection

ClinicalTrials.gov processed this record on October 01, 2014