Saline Irrigation After Surgery in Patients With Chronic Sinusitis (HVSI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Samuel Lunenfeld Research Institute, Mount Sinai Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
NeilMed Pharmaceuticals, donating saline bottles, no direct funding.
Information provided by (Responsible Party):
Kristian Macdonald, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01575223
First received: April 1, 2012
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

Purpose: To determine if high volume saline nasal irrigation (HVSI), (NeilMed® Sinus Rinse™) offers a benefit over low volume saline irrigation (LVSI), (Salinex®) in the early post-operative management in patients with chronic rhino sinusitis.


Condition Intervention Phase
Chronic Rhinosinusitis
Device: NeilMed sinus rinse
Device: Salinex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The HVSI STUDY: High Volume Saline Irrigation in the Post-operative Management of Chronic Rhinosinusitis: A Multicenter Randomized Single-Blind Controlled Trial

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Sinonasal Outcomes Scale (SNOT-22) [ Time Frame: One month post-operatively ] [ Designated as safety issue: No ]
    Subjective scale, completed by patient. Validated scale for chronic sinusitis.

  • Lund MacKay score [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]
    Objective scale, validated, completed by investigator. Preoperative CT scan is scored based on degree of sinus opacification (0-24).

  • Nasal and Sinus Symptom Score (NSS) - Subjective scale [ Time Frame: 1 month post-operatively ] [ Designated as safety issue: No ]
    A subjective scale, filled out by the patient, specific to symptoms of sinusitis.

  • Perioperative Sinus Endoscopy scale (POSE) [ Time Frame: 1 month post-operatively ] [ Designated as safety issue: No ]
    Objective scale, completed by treating physician, to assess sinonasal contents endoscopically. Validated scale.


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High volume saline irrigation
Patients in this group will receive high volume saline irrigation (NeilMed sinus rinse)
Device: NeilMed sinus rinse
High volume saline irrigation
Placebo Comparator: Placebo
Patients in this group will receive low volume saline irrigation (Salinex)
Device: Salinex
Low volume saline irrigation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Documented diagnosis of unilateral or bilateral CRS
  • Documented failed medical treatment of CRS
  • Eighteen (18) to sixty-five (65) years of age
  • Planned ESS for the treatment of CRS
  • Able to read and understand English

Exclusion criteria:

  • Pregnant
  • Cystic Fibrosis
  • Diagnosed immotile cilia syndrome
  • Diagnosed immunodeficiency syndrome
  • Diagnosed fungal sinusitis
  • Sinonasal tumours or obstructive lesions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575223

Contacts
Contact: Kristian I Macdonald, MD FRCSC 4166240614 kristian.macdonald@gmail.com
Contact: Ian J Witterick, MD MSc FRCSC 4165864800 iwitterick@mtsinai.on.ca

Locations
Canada, Alberta
University of Calgary Otolaryngology - Head & Neck Surgery Not yet recruiting
Calgary, Alberta, Canada, T5J 3E4
Contact: Luke Rudmik, MD FRCSC    4032708060    lukerudmik@gmail.com   
Sub-Investigator: Brad Mechor, MD FRCSC         
Canada, Ontario
Western University Dept. of Otolaryngology - Head & Neck Surgery Not yet recruiting
London, Ontario, Canada, N6A 3K7
Contact: Brian Rotenberg, MD FRCSC    5196466320    md.ent.rotenberg@gmail.com   
Ottawa University Otolaryngology - Head & Neck Surgery Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Shaun Kilty, MD FRCSC    6137292312    kiltysj@gmail.com   
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Kristian I Macdonald, MD FRCSC    4166240614    kristian.macdonald@gmail.com   
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
NeilMed Pharmaceuticals, donating saline bottles, no direct funding.
Investigators
Principal Investigator: Ian J Witterick, MD MSc FRCSC Samuel R Lunenfeld Institute
  More Information

Publications:
Responsible Party: Kristian Macdonald, Principal Investigator, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01575223     History of Changes
Other Study ID Numbers: HVSI-001
Study First Received: April 1, 2012
Last Updated: April 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
saline irrigation
chronic rhinosinusitis
endoscopic sinus surgery
high volume saline irrigation

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014