SinusitisPhase 1/2NCT01350193
Manuka Honey Irrigation After Sinus Surgery
A Phase 1/2 study testing Manuka Honey and Saline Irrigation in people with Sinusitis, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial summary
All adult (over 19 years) patients undergoing sinus surgery for chronic rhinosinusitis (CRS) or allergic fungal sinusitis (AFS) that do not meet the exclusion criteria will be included in the study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- Manuka Honey and Saline Irrigation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Apr 2013
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent.
- Adult (over 19 years of age) patients undergoing sinus surgery for chronic rhinosinusitis (CRS) or allergic fungal sinusitis (AFS).
Who cannot join
- Co-morbidities, eg. Hypertension, Cardiac Disease, Coagulopathy, CF, Sampter's triad, Diabetes, liver failure
- Medication, eg. Anticoagulants, statins, anti-hypertensives
- Allergies to honey, bee stings
Trial locations and contacts
1 site in 1 country.
Canada1 site
ENT Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Manuka Honey Irrigation After Endoscopic Sinus Surgery
All adult (over 19 years) patients undergoing sinus surgery for chronic rhinosinusitis (CRS) or allergic fungal sinusitis (AFS) that do not meet the exclusion criteria will be included in the study.
All participants enrolled in the study will receive antibiotic (Clavulin) therapy 1-week pre-and post-operatively and oral steroid therapy 1-week pre-operatively and post-operatively.
Read more
Randomization of patients to the Manuka Honey irrigation (treatment arm) and Saline irrigation (standard of care) will occur on the day of surgery.
Participants in both study arms will undergo the standard post-operative endoscopic sinus surgery follow-up. This includes follow-up appointments at 6 days, 5 weeks, 3 months, and 6 months of the post-operative period. During these appointments, the surgeon will assess the post-operative appearance (Philpott-Javer Sinus Rating System), number of infections, pain, and 1st week post-operative bleeding (only at 6 day visit).
The Sino-Nasal Outcome Test (SNOT-22) questionnaire is to be completed by the study participants at 6 days, 5 weeks, and 3 months of the post-operative period. The SNOT-22 is a 5-minute questionnaire consisting of 22 questions, which asks participants to rate their sinus symptoms and social/emotional consequences of their nasal disorder from "no problem" to "problem as bad as it can be."
Read the detailed description
All patients in this study will undergo endoscopic sinus surgery. This is the mainstay of treatment for patients with refractory sinus disease.
All patients that undergo endoscopic sinus surgery must routinely complete nasal irrigations to maintain the patency of the sinuses and to encourage healing. The current standard of treatment is saline irrigations. Manuka honey has already shown promise in the field of wound healing. The Manuka Honey will be used as the treatment arm in this study and will be compared to the current standard of care, the saline irrigations.
Once the subjects have signed the consent form, they will undergo endoscopic sinus surgery as planned. Randomization (using sealed envelopes) will occur immediately after surgery where patient will receive either the Honey rinse or Saline rinse. There will be 50 envelopes containing a sheet of paper stating "Manuka Honey Irrigation" and another 50 envelopes containing a sheet of paper stating "Saline Irrigation." These envelopes will be sealed, marked with "Nasal Irrigation Study" on the front of the envelope, and mixed in a random fashion. Immediately after surgery, one of these envelopes will be selected to randomize the patient to either the Manuka Honey or Saline irrigation arms. As this is a single-blinded study, the patients will know to which arm they are assigned to, while the primary investigator is blinded.
The standard treatment, as described involves nasal irrigation using a saline solution. This will constitute one arm of the study. The treatment arm will involve the use of the pasteurized Manuka honey nasal irrigation, which is not currently the standard of practice, but is approved by Health Canada to be used for this indication. The subject will use 30cc of the nasal irrigation (to which they are randomized) in each nostril twice daily (once in am, once in pm). No other specific manipulations will be used. The SNOT-22 questionnaire will be administered before the patient is assessed by the clinic physician at 6 days, 5 weeks, and 3 months post-operatively. Patients will not be blinded to the irrigation they are assigned to. The investigators will not know to which arm the subjects have been assigned to.
- Conditions
- Sinusitis
- Being tested
- Manuka Honey, Saline Irrigation
- Keywords
- Manuka Honey, Irrigation, Endoscopic Sinus Surgery
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka HoneyDevice
Also called Irrigation, Endoscopic Sinus Surgery
The use of the nasal irrigation on post-operative day #1. 30mL of the nasal irrigation will be applied to each nostril by a 60mL Toomey syringe (given to patient at pre-operative clinic visit) twice a day (once in am, once in pm). This will continue until the 6 month post-op visit.
Saline IrrigationOther
Also called Control, Endoscopic Sinus Surgery
The use of the nasal irrigation on post-operative day #1. 30mL of the nasal irrigation will be applied to each nostril by a 60mL Toomey syringe (given to patient at pre-operative clinic visit) twice a day (once in am, once in pm). This will continue until the 6 month post-op visit.
| Study group | Role | What they receive |
|---|---|---|
| Saline Nasal Irrigation | Active comparator | Saline Nasal Irrigation is actively being used as the standard of care. It does not contain any active ingredients. Receives: Other: Saline Irrigation |
| Manuka Honey Irrigation | Experimental | Manuka Honey Irrigation involves the experimental treatment of manuka honey nasal irrigation. Receives: Device: Manuka Honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative endoscopic appearance
Measured: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Post-Operative SNOT-22
Sino-Nasal Outcome Test (SNOT-22) is current standard in Rhinology for the assessment of the patient's subjective sinus symptoms and its effect on their daily functioning. It is composed of 22 questions, which ask patients to rate their symptoms on a scale of 0-5 (0=no problem, 5=problem as bad as it can be). Questions include patients perceived nasal congestion/blockage, facial pain, fatigue, sadness, etc. This questionnaire is used as the gold standard for patients to rate their subjective symptoms.
Measured: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Secondary outcomes (2)
Post-operative bleeding
Measured: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Post-operative pain
Measured: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Javer, St. Paul's Hospital, Canada
- Investigators
- Amin R Javer, MD, FRCSC, Principal investigator, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350193
- Sponsor's protocol ID
- MHI-2011
- Status last verified
- Dec 2013
- First submitted
- 3 May 2011
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cooper R. Using honey to inhibit wound pathogens. Nurs Times. 2008 Jan 22-28;104(3):46, 48-9.
PubMed 18293880English HK, Pack AR, Molan PC. The effects of manuka honey on plaque and gingivitis: a pilot study. J Int Acad Periodontol. 2004 Apr;6(2):63-7.
PubMed 15125017Armstrong DG. Manuka honey improved wound healing in patients with sloughy venous leg ulcers. Evid Based Med. 2009 Oct;14(5):148. doi: 10.1136/ebm.14.5.148. No abstract available.
PubMed 19794023Alandejani T, Marsan J, Ferris W, Slinger R, Chan F. Effectiveness of honey on Staphylococcus aureus and Pseudomonas aeruginosa biofilms. Otolaryngol Head Neck Surg. 2009 Jul;141(1):114-8. doi: 10.1016/j.otohns.2009.01.005. Epub 2009 Mar 9.
PubMed 19559969
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manuka Honey Irrigation After Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT01350193
- Acronym / sponsor ID
- MHI-2011
- Conditions
- Sinusitis
- Keywords
- Manuka Honey, Irrigation, Endoscopic Sinus Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 May 2011 (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.
All adult (over 19 years) patients undergoing sinus surgery for chronic rhinosinusitis (CRS) or allergic fungal sinusitis (AFS) that do not meet the exclusion criteria will be included in the study.
All participants enrolled in the study will receive antibiotic (Clavulin) therapy 1-week pre-and post-operatively and oral steroid therapy 1-week pre-operatively and post-operatively.
Randomization of patients to the Manuka Honey irrigation (treatment arm) and Saline irrigation (standard of care) will occur on the day of surgery.
Participants in both study arms will undergo the standard post-operative endoscopic sinus surgery follow-up. This includes follow-up appointments at 6 days, 5 weeks, 3 months, and 6 months of the post-operative period. During these appointments, the surgeon will assess the post-operative appearance (Philpott-Javer Sinus Rating System), number of infections, pain, and 1st week post-operative bleeding (only at 6 day visit).
The Sino-Nasal Outcome Test (SNOT-22) questionnaire is to be completed by the study participants at 6 days, 5 weeks, and 3 months of the post-operative period. The SNOT-22 is a 5-minute questionnaire consisting of 22 questions, which asks participants to rate their sinus symptoms and social/emotional consequences of their nasal disorder from "no problem" to "problem as bad as it can be."
Detailed description
All patients in this study will undergo endoscopic sinus surgery. This is the mainstay of treatment for patients with refractory sinus disease.
All patients that undergo endoscopic sinus surgery must routinely complete nasal irrigations to maintain the patency of the sinuses and to encourage healing. The current standard of treatment is saline irrigations. Manuka honey has already shown promise in the field of wound healing. The Manuka Honey will be used as the treatment arm in this study and will be compared to the current standard of care, the saline irrigations.
Once the subjects have signed the consent form, they will undergo endoscopic sinus surgery as planned. Randomization (using sealed envelopes) will occur immediately after surgery where patient will receive either the Honey rinse or Saline rinse. There will be 50 envelopes containing a sheet of paper stating "Manuka Honey Irrigation" and another 50 envelopes containing a sheet of paper stating "Saline Irrigation." These envelopes will be sealed, marked with "Nasal Irrigation Study" on the front of the envelope, and mixed in a random fashion. Immediately after surgery, one of these envelopes will be selected to randomize the patient to either the Manuka Honey or Saline irrigation arms. As this is a single-blinded study, the patients will know to which arm they are assigned to, while the primary investigator is blinded.
The standard treatment, as described involves nasal irrigation using a saline solution. This will constitute one arm of the study. The treatment arm will involve the use of the pasteurized Manuka honey nasal irrigation, which is not currently the standard of practice, but is approved by Health Canada to be used for this indication. The subject will use 30cc of the nasal irrigation (to which they are randomized) in each nostril twice daily (once in am, once in pm). No other specific manipulations will be used. The SNOT-22 questionnaire will be administered before the patient is assessed by the clinic physician at 6 days, 5 weeks, and 3 months post-operatively. Patients will not be blinded to the irrigation they are assigned to. The investigators will not know to which arm the subjects have been assigned to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Nasal Irrigation | Active comparator | Other: Saline IrrigationSaline Nasal Irrigation is actively being used as the standard of care. It does not contain any active ingredients. |
| Manuka Honey Irrigation | Experimental | Device: Manuka HoneyManuka Honey Irrigation involves the experimental treatment of manuka honey nasal irrigation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to provide informed consent.
- Adult (over 19 years of age) patients undergoing sinus surgery for chronic rhinosinusitis (CRS) or allergic fungal sinusitis (AFS).
Key exclusion criteria (3 listed)
- Co-morbidities, eg. Hypertension, Cardiac Disease, Coagulopathy, CF, Sampter's triad, Diabetes, liver failure
- Medication, eg. Anticoagulants, statins, anti-hypertensives
- Allergies to honey, bee stings
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 |
|---|---|---|
| Manuka HoneyAlso: Irrigation, Endoscopic Sinus SurgeryThe use of the nasal irrigation on post-operative day #1. 30mL of the nasal irrigation will be applied to each nostril by a 60mL Toomey syringe (given to patient at pre-operative clinic visit) twice a day (once in am, once in pm). This will continue until the 6 month post-op visit. | Device | Manuka Honey Irrigation |
| Saline IrrigationAlso: Control, Endoscopic Sinus SurgeryThe use of the nasal irrigation on post-operative day #1. 30mL of the nasal irrigation will be applied to each nostril by a 60mL Toomey syringe (given to patient at pre-operative clinic visit) twice a day (once in am, once in pm). This will continue until the 6 month post-op visit. | Other | Saline Nasal Irrigation |
Primary outcome
Post-operative endoscopic appearance
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Post-Operative SNOT-22
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Sino-Nasal Outcome Test (SNOT-22) is current standard in Rhinology for the assessment of the patient's subjective sinus symptoms and its effect on their daily functioning. It is composed of 22 questions, which ask patients to rate their symptoms on a scale of 0-5 (0=no problem, 5=problem as bad as it can be). Questions include patients perceived nasal congestion/blockage, facial pain, fatigue, sadness, etc. This questionnaire is used as the gold standard for patients to rate their subjective symptoms.
2 secondary outcomes
Post-operative bleeding
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Post-operative pain
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Background: PubMed 18293880Cooper R. Using honey to inhibit wound pathogens. Nurs Times. 2008 Jan 22-28;104(3):46, 48-9.
- Results publication: PubMed 15125017English HK, Pack AR, Molan PC. The effects of manuka honey on plaque and gingivitis: a pilot study. J Int Acad Periodontol. 2004 Apr;6(2):63-7.
- Results publication: PubMed 19794023Armstrong DG. Manuka honey improved wound healing in patients with sloughy venous leg ulcers. Evid Based Med. 2009 Oct;14(5):148. doi: 10.1136/ebm.14.5.148. No abstract available.
- Results publication: PubMed 19559969Alandejani T, Marsan J, Ferris W, Slinger R, Chan F. Effectiveness of honey on Staphylococcus aureus and Pseudomonas aeruginosa biofilms. Otolaryngol Head Neck Surg. 2009 Jul;141(1):114-8. doi: 10.1016/j.otohns.2009.01.005. Epub 2009 Mar 9.
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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.
Amin R Javer, MD, FRCSC principal investigator
St. Paul's Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Manuka Honey and Saline Irrigation in people with Sinusitis, run by St. Paul's Hospital, Canada at 1 site in Canada.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 4 Dec 2013. 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative endoscopic appearance (time frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01350193, which also lists 4 linked publications.
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 4 Dec 2013.