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

NCT01399021 | Unknown

• 1 other identifier: H11-01434
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Parotidectomy

Keywords

Parotidectomy; Drain removal; Timing; Hematoma; Surgical wound infection

Outcome Measures

Primary Outcomes (1)

• Rate of hematoma formation

  The proportions of hematoma formation in patients with early drain removal compared to later drain removal will be assessed

  Hematoma formed within 30 days after the surgery

Secondary Outcomes (1)

• Rate of infection

  Within 30 days following surgery

Study Arms (1)

Flat Davol drain

OTHER

both arms will have flat davol drains placed at the end of the parotidectomy surgery

Other: Early Drain Removal; Other: Late Drain Removal

Interventions

Early Drain Removal OTHER

Drain will be removed prior to patient's discharge on the day of the surgery

Flat Davol drain

Late Drain Removal OTHER

Patient will be seen on the day following the surgery to have the drain removed

Flat Davol drain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (4)

Eagle Ridge Hospital

Port Moody, British Columbia, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Hematoma; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wound Infection; Infections; Postoperative Complications

Study Officials

• Donald W Anderson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronique Wan Fook Cheung, MDCM

CONTACT

604-992-7752; veroniquewan@gmail.com

Donald W Anderson, MD

CONTACT

604-941-9191; dwa@shaw.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 21, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

CA (4)