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

NCT00595608 | Unknown Phase 4 DMC

• 1 other identifier: 07/S0802/45
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Surgery

Keywords

aftercare; nasal septum; turbinates

Outcome Measures

Primary Outcomes (1)

• On the 3rd and 7th postoperative day, patients will judge their symptoms on that day, using VAS.

  Day 3 and 7

Secondary Outcomes (1)

• The patient should record painkillers needed on a daily basis for 7 days and will be provided with an EQ-5D health questionnaire.

  7 days

Study Arms (2)

1

ACTIVE COMPARATOR

Nasal Sterimar spray

Drug: Sterimar Spray

2

ACTIVE COMPARATOR

Nasal saline spray

Drug: Generic homemade nasal saline spray (salt and water)

Interventions

Sterimar Spray DRUG

Post-op nasal spray, three times a day

Also known as: Sterimar nasal seawater spray

1

Generic homemade nasal saline spray (salt and water) DRUG

post op nasal saline spray in syringe, three times a day

Also known as: generic salt water solution

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Grampian: lead

Study Sites (1)

Department of Otorhinolaryngology, Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

MeSH Terms

Interventions

Salts; Water

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Kim W Ah-See, MD, FRCS

  NHS Grampian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil McCluney

CONTACT

0044 1224; neilmccluney@hotmail.com

Gundula Thiel, MD

CONTACT

gundulathiel@doctors.org.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 16, 2008

Record last verified: 2007-12

Locations

GB (1)