In this study we will compare the therapeutic value of nasal saline irrigations only versus nasal saline irrigations combined with nasal application of STB* ointment in patients who received inferior turbinate coblation by radiofrequency (ITC-RF).…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective: is there a significant difference in the overall nasal VAS
symptom score between saline only nasal irrigations versus saline nasal
irrigations and nasal application of STB* wound dressing?
The primary endpoint will be the overall VAS symptom score after 6 weeks of
treatment (initial treatment), comparing the two different treatments arms.
Secondary outcome
Secundary parameters:
- Comparison of nasal patency by means of NL-NOSE scale (questionnaire)
- Comparison of nasal endoscopic findings (NES score)
- Comparison of PNIF-score before and after treatment.
- Comparison of the burden of epistaxis (5-point scale).
- Comparison of the burden of nasal discharge (5-point scale).
- Difference in VAS symptom score for crust formation. (VAS)
- Difference in VAS symptom score for nasal pain. (VAS)
- Difference in VAS symptom score for loss of smell. (VAS)
Background summary
A common complaint within the ENT practice is nasal obstruction for which
surgical treatment is often applied, in case conservative treatment fails.
Although there is a broad spectrum of etiologies, there is a general
distinction between two categories of nasal obstruction: 1) reversible nasal
obstruction, which is usually caused by inflammation of de mucosa along with
secretion; 2) fixed obstruction, which is usually caused by occlusion,
anatomical variation or neoplasms. One of the causes of fixed obstruction is
turbinate hypertrophy, which may be sustained by inflammation caused by
allergic rhinitis (AR) or non-allergic rhinitis (NAR).
The nasal turbinates are located on either site within the nose, respectively
the inferior, medial and superior turbinates. The inferior turbinate alone
causes about 50% of the total resistance of airflow through the nose, which
means that the feeling of obstruction already occurs at minor swelling of the
inferior turbinate. It is possible to evaluate subjective nasal obstruction by
means of validated questionnaires and VAS. PNIF provides an objective way of
measurement of airflow through the nose in which a patient is asked to inhale
as powerful and quickly as possible. It is a non-invasive, cheap and easy
method to use.
One of the possible ways to treat ITH is the use of ITC-RF, a method which is
regularly used. ITC-RF can be performed at outpatient consultation, without
major risks, by using local anesthesia. With ITC-RF the submucosal tissue of
the turbinate is scarred, with the use of radiofrequent energy. This results in
shrinkage of the turbinate. The radiofrequent energy is transferred by a sharp
pointed probe which is brought into the turbinate. Although the invasive
character of this intervention is minor, there is still an iatrogenic cause of
wound formation within the nose. The cornerstone of treatment after ITC-RF
consists of nasal saline irrigations. Patients are advised to irrigate the nose
three times daily for six weeks.
STB* is an ointment which is based on medicinal honey. Medicinal honey has
gained relative prominence over the past years within the field of wound
healing. Previous research has shown that medicinal honey contains
characteristics which are essential for the healing of wounds, such as
suppressing long term inflammation and stimulation of anti-inflammatory
cytokines. Its thick viscosity and low pH have an anti-bacterial effect and
since it does not contain corticosteroids or antibiotics it is safe to use for
a longer period of time
STB* nasal woundressing is well tolerated and widely used in ENT practice for
the treatment of epistaxis or to diminish crusting of the nasal mucosa in for
example nasal Granulomatosis with polyangiitis. Nevertheless, no studies have
been performed to address it*s effectiveness in these nasal diseases.
It is available at the pharmacist and medicine specialty store with the
prescription of a physician or physician-assistant. With possession of a
prescription, STB* is reimbursed by the health insurance. NasuMel®, which is
the same ointment as STB* wounddressing, is freely available for patients.
Study objective
In this study we will compare the therapeutic value of nasal saline irrigations
only versus nasal saline irrigations combined with nasal application of STB*
ointment in patients who received inferior turbinate coblation by
radiofrequency (ITC-RF). We will investigate several parameters by means of a
validated questionnaire (NL-NOSE scale), VAS symptom scores, endoscopic
findings and an objective measurement of nasal patency by means of a Peak Nasal
Inspiratory Flow (PNIF).
Study design
This study will be a single centre single-blind, randomized study in 64
subjects who have inferior turbinate hypertrophy and who have an indication for
coblation treatment, who did not already receive surgical treatment for the
inferior turbinate.
Subjects will be treated 3 times daily during 6 weeks with saline only- or
saline nasal irrigations and nasal application of STB* ointment 3 times daily.
Subjects will be randomized to saline only nasal irrigations or saline nasal
irrigations and nasal application of STB* ointment.
Signs and symptoms will be measured with disease specific questionnaires. Nasal
endoscopy and PNIF will give more objective information about the improvement
status.
Intervention
Subjects in group 1 will be treated 3 times daily during 6 weeks with saline
nasal irrigations only. Group 2 will be treated withsaline nasal irrigations
and nasal application of STB* wound dressing 3 times daily.
Study burden and risks
At visit 1 the participant will fill in the NL-NOSE questionnaire (5
questions), and one other short questionnaire and perform a Peak Nasal
Inspiratory Flow measurement. Every week the participant will receive a short
questionnaire (maximum 5 minutes) by e-mail (6 questionnaires in total).
For 6 weeks 3 times a day one group will irrigate the nose with saline only.
The other group will get this same treatment with the addition of applying STB*
wound dressing in the nose.
The extent of the burden is low, because a part of the treatment is standard
care.
There are no additional risks.
Dr. van Heesweg 2 nvt
Zwolle 8025 AB
NL
Dr. van Heesweg 2 nvt
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
1. Subjects must have a diagnosis of bilateral inferior turbinate hypertrophy
for > 6 weeks
2. Patients are capable of undergoing the coblation procedure under local
anesthesia
3. Age * 18 and * 70 years.
4. Subjects must be willing to give Informed Consent and adhere to visit
schedules.
Exclusion criteria
1. Subjects currently treated with anticoagulation other than thrombocyte
aggregation inhibitors.
2. The presence of nasal polyps.
3. Known systemic vasculitic and granulomatous disease.
4. Known coagulopathy.
5. Known peanut allergy.
6. AIDS or known to be HIV positive.
7. Smoking (in the past 6 months).
8. History of radiotherapy in head and neck region.
9. History of previous turbinate surgery
10. Severe anatomic abnormalities leading to an inability to administer the
irrigation solution to one side of the nose.
11. Nose valve insufficiency.
12. Craniofacial malformations.
13. Abnormalities requiring other modality of therapy (obstructive polyps,
tumors, infection of dental origin).
14. Subject has a psychiatric, addictive, or any disorder that compromises
ability to give truly Informed Consent for participation in this study.
15. Subject may have difficulty in interpreting the questionnaires due to
language or cognitive problems.
16. Patient is currently enrolled in other investigational drug trial(s) or is
receiving other investigational agent(s).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70712.075.19 |