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

This study has been completed.
Sponsor:
Collaborator:
NeilMed Pharmaceuticals
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 22, 2014
Last verified: April 2014
  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.


Enrollment: 86
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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
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: NCT01575223

Locations
Canada, Alberta
University of Calgary Otolaryngology - Head & Neck Surgery
Calgary, Alberta, Canada, T5J 3E4
Canada, Ontario
Western University Dept. of Otolaryngology - Head & Neck Surgery
London, Ontario, Canada, N6A 3K7
Ottawa University Otolaryngology - Head & Neck Surgery
Ottawa, Ontario, Canada, K1Y 4E9
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
NeilMed Pharmaceuticals
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 22, 2014
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 July 31, 2014