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

Sponsor:	NHS Grampian
Information provided by:	NHS Grampian
ClinicalTrials.gov Identifier:	NCT00595608

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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Dietary Sodium Drinking Water Surgery

Drug Information available for: Sodium chloride

U.S. FDA Resources

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
1: Active Comparator Nasal Sterimar spray	Drug: Sterimar Spray Post-op nasal spray, three times a day
2: Active Comparator Nasal saline spray	Drug: Generic homemade nasal saline spray (salt and water) post op nasal saline spray in syringe, three times a day

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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

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, Scotland
Department of Otorhinolaryngology, Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN

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 ( NHS Grampian, R&D department )
Study ID Numbers:	07/S0802/45, 07/S0802/45
Study First Received:	January 7, 2008
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00595608 History of Changes
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 November 27, 2009