Nasal SurgeryPhase 4NCT00595608
Sterimar vs Saline Sprays in Nasal Surgical Aftercare - a Blinded, Randomised Trial
A Phase 4 study testing Sterimar Spray and Generic homemade nasal saline spray (salt and water) in people with Nasal Surgery, run by NHS Grampian at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nasal Surgery
- What is being tested?
- Sterimar Spray and Generic homemade nasal saline spray (salt and water)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing septoplasty and septoplasty in conjuction with turbinate surgery will be recruited.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Gundula Thiel, MD contact
United Kingdom1 site
Department of Otorhinolaryngology, Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Neil McCluney
About this study
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.
Read more
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.
Read the detailed description
Project Proposal
Sterimar vs Saline Sprays in nasal surgical aftercare - a blinded, randomised trial.
Gundula Thiel, Andy Evans, Kim Ah-See
Background
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. These are intended to reduce swelling and crusting and their resultant symptoms.
There is currently no level 1 evidence in literature to support the use of any particular preparation over others in nasal surgical aftercare.
A recent randomised controlled trial carried out in this department, comparing use of xylometazoline based decongestants vs Sterimar seawater nasal spray, showed a lower pain scoring in the Sterimar group but no other significant differences. This study is as yet unpublished.
Sterimar spray is a spray made from seawater which is diluted to make the solution isotonic.
Traditionally, other forms of Saline sniffs and rinses are also used for the above mentioned applications.
It is easy to make up an isotonic saline solution, using 5 grams of salt (1 teaspoon) for every ½ litre of boiled water. This can then, after cooling off, be applied to the nasal cavities with the help of a standard 10 ml syringe which is provided to the patient at discharge.
As Sterimar is not yet on the hospital formulary, the cost for the treatment is currently borne by the patient. For the duration of the study, patients randomized into the Sterimar group will be provided with the medication free of charge.
We consider it unlikely that patients randomised into the saline spray group will supplement this treatment by buying further saline sprays from the chemist at their own expense.
To establish this and to follow up patients after the trial period, we will establish a research clinic. Patients will be reviewed in a clinic dedicated to patients taking part in this trial approximately 2 weeks after surgery, after completion of the trial period.
The trial will help to establish efficacy and symptom control and advantages of one solution and delivery device over the other.
If home-made saline sprays could be used to similar effect as Sterimar, the cost for this form of surgical aftercare could be lowered significantly, both for the patient and the NHS.
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 MHRA confirmed that neither the Sterimar nor the home made saline spray are considered Investigational Medicinal Products.
Methodology
Setting
ENT unit, Aberdeen Royal Infirmary, teaching hospital
Inclusions / exclusions
Patients undergoing septoplasty and septoplasty in conjunction with turbinate surgery will be recruited. 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.
Recruitment
Patients fitting the inclusion criteria will be approached in the Outpatients clinic. The decision for septoplasty +/- turbinate surgery will be made there and consent for the operation will be taken. A patient information sheet will be administered by the lead investigator or other medical staff on the same day, allowing the patient ample time to discuss the matter with relatives and medical staff. Patients will be left to read the information sheet and then re-approached to assess willingness to be included in the trial. The procedure of the trial will be further explained and informed consent to take part will be obtained. Patients will retain the patient information sheet as well as receive a scoring sheet containing visual analogue scales to assess symptoms - pain, running, sense of smell, bleeding, blockage. A questionnaire assessing use of post-operative analgesia for 7 days on a daily basis will also be included.
All these forms will be on appropriately headed paper. A clear explanation of how to complete the assessment sheet will be given. The patient will be approached again on the pre-operative morning and Patients will be randomised using a randomisation schedule generated by NHS Grampian Research \& Development Dept.
can withdraw his/her consent to the trial at any time. Randomisation
Patients will be randomised using a randomisation schedule generated by NHS Grampian Research \& Development Dept.
Treatment
Based on the randomisation, patients will be given one of either saline sprays or Sterimar Physiological Sea Water Microspray. Instructions regarding use will be given including frequency and technique.
Outcome measures
On the 3rd and 7th postoperative day, patients will complete the symptom assessment sheet judging their symptoms on that day.
The patient should record painkillers needed on the Analgesia Requirement Sheet on a daily basis for 7 days.
The patients will also be provided with an EQ-5D health questionnaire, which is well validated and has referent look up values for populations of ill and healthy patients.
These will be returned in a pre-paid envelope and will be identifiable only by the patients' study number retained in the randomisation program.
Analysis
Visual analogue scales will be analyzed by investigators blinded to which treatment has been administered.
Results will be further analysed comparing scores achieved for those taking saline sniffs and those taking Sterimar. Tests of statistical significance will be performed to establish if either preparation is superior in symptom control. Analgesia use will be taken into consideration.
To select a difference in symptom scores on a visual analogue scale of 10mm or more at the level of significance with 80% power, a sample size of 60 patients is required in each arm of the trial. This is assuming a standard deviation of 19mm, which was demonstrated in the study previously conducted in this department.
- Conditions
- Nasal Surgery
- Being tested
- Sterimar Spray, Generic homemade nasal saline spray (salt and water)
- Keywords
- aftercare, nasal septum, turbinates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterimar SprayDrug
Also called Sterimar nasal seawater spray
Post-op nasal spray, three times a day
Generic homemade nasal saline spray (salt and water)Drug
Also called generic salt water solution
post op nasal saline spray in syringe, three times a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Nasal Sterimar spray Receives: Drug: Sterimar Spray |
| 2 | Active comparator | Nasal saline spray Receives: Drug: Generic homemade nasal saline spray (salt and water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
On the 3rd and 7th postoperative day, patients will judge their symptoms on that day, using VAS.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Investigators
- Kim W Ah-See, MD, FRCS, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595608
- Sponsor's protocol ID
- 07/S0802/45
- Other IDs
- 07/S0802/45
- Status last verified
- Dec 2007
- First submitted
- 7 Jan 2008
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sterimar vs Saline Sprays in Nasal Surgical Aftercare - a Blinded, Randomised Trial
- ClinicalTrials.gov ID
- NCT00595608
- Acronym / sponsor ID
- 07/S0802/45
- Conditions
- Nasal Surgery
- Keywords
- aftercare, nasal septum, turbinates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NHS GrampianOther government
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Project Proposal
Sterimar vs Saline Sprays in nasal surgical aftercare - a blinded, randomised trial.
Gundula Thiel, Andy Evans, Kim Ah-See
Background
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. These are intended to reduce swelling and crusting and their resultant symptoms.
There is currently no level 1 evidence in literature to support the use of any particular preparation over others in nasal surgical aftercare.
A recent randomised controlled trial carried out in this department, comparing use of xylometazoline based decongestants vs Sterimar seawater nasal spray, showed a lower pain scoring in the Sterimar group but no other significant differences. This study is as yet unpublished.
Sterimar spray is a spray made from seawater which is diluted to make the solution isotonic.
Traditionally, other forms of Saline sniffs and rinses are also used for the above mentioned applications.
It is easy to make up an isotonic saline solution, using 5 grams of salt (1 teaspoon) for every ½ litre of boiled water. This can then, after cooling off, be applied to the nasal cavities with the help of a standard 10 ml syringe which is provided to the patient at discharge.
As Sterimar is not yet on the hospital formulary, the cost for the treatment is currently borne by the patient. For the duration of the study, patients randomized into the Sterimar group will be provided with the medication free of charge.
We consider it unlikely that patients randomised into the saline spray group will supplement this treatment by buying further saline sprays from the chemist at their own expense.
To establish this and to follow up patients after the trial period, we will establish a research clinic. Patients will be reviewed in a clinic dedicated to patients taking part in this trial approximately 2 weeks after surgery, after completion of the trial period.
The trial will help to establish efficacy and symptom control and advantages of one solution and delivery device over the other.
If home-made saline sprays could be used to similar effect as Sterimar, the cost for this form of surgical aftercare could be lowered significantly, both for the patient and the NHS.
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 MHRA confirmed that neither the Sterimar nor the home made saline spray are considered Investigational Medicinal Products.
Methodology
Setting
ENT unit, Aberdeen Royal Infirmary, teaching hospital
Inclusions / exclusions
Patients undergoing septoplasty and septoplasty in conjunction with turbinate surgery will be recruited. 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.
Recruitment
Patients fitting the inclusion criteria will be approached in the Outpatients clinic. The decision for septoplasty +/- turbinate surgery will be made there and consent for the operation will be taken. A patient information sheet will be administered by the lead investigator or other medical staff on the same day, allowing the patient ample time to discuss the matter with relatives and medical staff. Patients will be left to read the information sheet and then re-approached to assess willingness to be included in the trial. The procedure of the trial will be further explained and informed consent to take part will be obtained. Patients will retain the patient information sheet as well as receive a scoring sheet containing visual analogue scales to assess symptoms - pain, running, sense of smell, bleeding, blockage. A questionnaire assessing use of post-operative analgesia for 7 days on a daily basis will also be included.
All these forms will be on appropriately headed paper. A clear explanation of how to complete the assessment sheet will be given. The patient will be approached again on the pre-operative morning and Patients will be randomised using a randomisation schedule generated by NHS Grampian Research \& Development Dept.
can withdraw his/her consent to the trial at any time. Randomisation
Patients will be randomised using a randomisation schedule generated by NHS Grampian Research \& Development Dept.
Treatment
Based on the randomisation, patients will be given one of either saline sprays or Sterimar Physiological Sea Water Microspray. Instructions regarding use will be given including frequency and technique.
Outcome measures
On the 3rd and 7th postoperative day, patients will complete the symptom assessment sheet judging their symptoms on that day.
The patient should record painkillers needed on the Analgesia Requirement Sheet on a daily basis for 7 days.
The patients will also be provided with an EQ-5D health questionnaire, which is well validated and has referent look up values for populations of ill and healthy patients.
These will be returned in a pre-paid envelope and will be identifiable only by the patients' study number retained in the randomisation program.
Analysis
Visual analogue scales will be analyzed by investigators blinded to which treatment has been administered.
Results will be further analysed comparing scores achieved for those taking saline sniffs and those taking Sterimar. Tests of statistical significance will be performed to establish if either preparation is superior in symptom control. Analgesia use will be taken into consideration.
To select a difference in symptom scores on a visual analogue scale of 10mm or more at the level of significance with 80% power, a sample size of 60 patients is required in each arm of the trial. This is assuming a standard deviation of 19mm, which was demonstrated in the study previously conducted in this department.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Sterimar SprayNasal Sterimar spray |
| 2 | Active comparator | Drug: Generic homemade nasal saline spray (salt and water)Nasal saline spray |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing septoplasty and septoplasty in conjuction with turbinate surgery will be recruited.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterimar SprayAlso: Sterimar nasal seawater sprayPost-op nasal spray, three times a day | Drug | 1 |
| Generic homemade nasal saline spray (salt and water)Also: generic salt water solutionpost op nasal saline spray in syringe, three times a day | Drug | 2 |
Primary outcome
On the 3rd and 7th postoperative day, patients will judge their symptoms on that day, using VAS.
Time frame: Day 3 and 7
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gundula Thiel, MD contact
Kim W Ah-See, MD, FRCS principal investigator
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sterimar Spray and Generic homemade nasal saline spray (salt and water) in people with Nasal Surgery, run by NHS Grampian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neil McCluney (0044 1224 ext. 552097, neilmccluney@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
On the 3rd and 7th postoperative day, patients will judge their symptoms on that day, using VAS. (time frame: Day 3 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2008.