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
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|
|Intervention Model:||Parallel Assignment|
|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|
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
- On the 3rd and 7th postoperative day, patients will judge their symptoms on that day, using VAS. [ Time Frame: Day 3 and 7 ]
- 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 ]
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
|Contact: Neil McCluney||0044 1224 ext firstname.lastname@example.org|
|Contact: Gundula Thiel, MDemail@example.com|
|Department of Otorhinolaryngology, Aberdeen Royal Infirmary||Not yet recruiting|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Sub-Investigator: Neil McCluney|
|Principal Investigator:||Kim W Ah-See, MD, FRCS||NHS Grampian|