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Sterimar vs Saline Sprays in Nasal Surgical Aftercare - a Blinded, Randomised Trial

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ClinicalTrials.gov Identifier: NCT00595608
Recruitment Status : Unknown
Verified December 2007 by NHS Grampian.
Recruitment status was:  Not yet recruiting
First Posted : January 16, 2008
Last Update Posted : January 16, 2008
Sponsor:
Information provided by:
NHS Grampian

Brief Summary:

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 or disease Intervention/treatment Phase
Nasal Surgery Drug: Sterimar Spray Drug: Generic homemade nasal saline spray (salt and water) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Sterimar vs Saline Sprays in Nasal Surgical Aftercare - a Blinded, Randomised Trial
Study Start Date : February 2008
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : February 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. On the 3rd and 7th postoperative day, patients will judge their symptoms on that day, using VAS. [ Time Frame: Day 3 and 7 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: NHS Grampian, R&D department, NHS Grampian
ClinicalTrials.gov Identifier: NCT00595608     History of Changes
Other Study ID Numbers: 07/S0802/45
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: December 2007

Keywords provided by NHS Grampian:
aftercare
nasal septum
turbinates