Trial record 1 of 6 for:    S0802
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Sterimar vs Saline Sprays in Nasal Surgical Aftercare - a Blinded, Randomised Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by NHS Grampian.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
NHS Grampian
ClinicalTrials.gov Identifier:
NCT00595608
First received: January 7, 2008
Last updated: January 15, 2008
Last verified: December 2007
  Purpose

Patients undergoing nasal surgery commonly experience a variety of symptoms in the post-operative period including blockage, running, pain, bleeding and reduction in sense of smell. A variety of preparations are currently recommended for symptomatic relief in the post operative period. These include saline irrigations and sniffs, steam inhalations, decongestants and steroid drops.

There is currently no level 1 evidence in literature to support the use of any particular preparation over others in nasal surgical aftercare.

We propose to conduct a single blinded, randomised trial comparing saline sprays vs Sterimar, a commercially available aerosolised isotone saline solution, comparing patients' symptom scores following septal surgery.

The trial will help to establish efficacy and symptom control and advantages of one solution and delivery device over the other.


Condition Intervention Phase
Nasal Surgery
Drug: Sterimar Spray
Drug: Generic homemade nasal saline spray (salt and water)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Sterimar vs Saline Sprays in Nasal Surgical Aftercare - a Blinded, Randomised Trial

Resource links provided by NLM:


Further study details as provided by NHS Grampian:

Primary Outcome Measures:
  • On the 3rd and 7th postoperative day, patients will judge their symptoms on that day, using VAS. [ Time Frame: Day 3 and 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The patient should record painkillers needed on a daily basis for 7 days and will be provided with an EQ-5D health questionnaire. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Nasal Sterimar spray
Drug: Sterimar Spray
Post-op nasal spray, three times a day
Other Name: Sterimar nasal seawater spray
Active Comparator: 2
Nasal saline spray
Drug: Generic homemade nasal saline spray (salt and water)
post op nasal saline spray in syringe, three times a day
Other Name: generic salt water solution

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing septoplasty and septoplasty in conjuction with turbinate surgery will be recruited.

Exclusion Criteria:

  • Those undergoing additional procedures including polypectomy will be excluded, as will all patients whose post-operative recommendations are for steroids or other take home medications that may bias results.
  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: NCT00595608

Contacts
Contact: Neil McCluney 0044 1224 ext 552097 neilmccluney@hotmail.com
Contact: Gundula Thiel, MD gundulathiel@doctors.org.uk

Locations
United Kingdom
Department of Otorhinolaryngology, Aberdeen Royal Infirmary Not yet recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Sub-Investigator: Neil McCluney         
Sponsors and Collaborators
NHS Grampian
Investigators
Principal Investigator: Kim W Ah-See, MD, FRCS NHS Grampian
  More Information

No publications provided

Responsible Party: NHS Grampian, R&D department, NHS Grampian
ClinicalTrials.gov Identifier: NCT00595608     History of Changes
Other Study ID Numbers: 07/S0802/45, 07/S0802/45
Study First Received: January 7, 2008
Last Updated: January 15, 2008
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by NHS Grampian:
aftercare
nasal septum
turbinates

ClinicalTrials.gov processed this record on July 23, 2014