Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT00595608 |
| Other study ID # |
07/S0802/45 |
| Secondary ID |
07/S0802/45 |
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
January 7, 2008 |
| Last updated |
January 15, 2008 |
| Start date |
February 2008 |
| Est. completion date |
February 2010 |
Study information
| Verified date |
December 2007 |
| Source |
NHS Grampian |
| Contact |
Neil McCluney |
| Phone |
0044 1224 |
| Email |
neilmccluney[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee |
| Study type |
Interventional
|
Clinical 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. 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.
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.
