Manuka Honey Irrigation After Sinus Surgery
Primary Purpose
Sinusitis
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Manuka Honey
Saline Irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis focused on measuring Manuka Honey, Irrigation, Endoscopic Sinus Surgery
Eligibility Criteria
Inclusion Criteria:
- Ability to provide informed consent.
- Adult (over 19 years of age) patients undergoing sinus surgery for chronic rhinosinusitis (CRS) or allergic fungal sinusitis (AFS).
Exclusion Criteria:
- 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
Sites / Locations
- ENT Clinic, St. Paul's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Saline Nasal Irrigation
Manuka Honey Irrigation
Arm Description
Saline Nasal Irrigation is actively being used as the standard of care. It does not contain any active ingredients.
Manuka Honey Irrigation involves the experimental treatment of manuka honey nasal irrigation.
Outcomes
Primary Outcome Measures
Post-operative endoscopic appearance
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.
Secondary Outcome Measures
Post-operative bleeding
Post-operative pain
Full Information
NCT ID
NCT01350193
First Posted
May 3, 2011
Last Updated
December 2, 2013
Sponsor
St. Paul's Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT01350193
Brief Title
Manuka Honey Irrigation After Sinus Surgery
Official Title
Manuka Honey Irrigation After Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Paul's Hospital, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
Manuka Honey, Irrigation, Endoscopic Sinus Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline Nasal Irrigation
Arm Type
Active Comparator
Arm Description
Saline Nasal Irrigation is actively being used as the standard of care. It does not contain any active ingredients.
Arm Title
Manuka Honey Irrigation
Arm Type
Experimental
Arm Description
Manuka Honey Irrigation involves the experimental treatment of manuka honey nasal irrigation.
Intervention Type
Device
Intervention Name(s)
Manuka Honey
Other Intervention Name(s)
Irrigation, Endoscopic Sinus Surgery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline Irrigation
Other Intervention Name(s)
Control, Endoscopic Sinus Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Title
Post-Operative SNOT-22
Description
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.
Time Frame
Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Secondary Outcome Measure Information:
Title
Post-operative bleeding
Time Frame
Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Title
Post-operative pain
Time Frame
Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to provide informed consent.
Adult (over 19 years of age) patients undergoing sinus surgery for chronic rhinosinusitis (CRS) or allergic fungal sinusitis (AFS).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amin R Javer, MD, FRCSC
Organizational Affiliation
St. Paul's Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
ENT Clinic, St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18293880
Citation
Cooper R. Using honey to inhibit wound pathogens. Nurs Times. 2008 Jan 22-28;104(3):46, 48-9.
Results Reference
background
PubMed Identifier
15125017
Citation
English 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 Reference
result
PubMed Identifier
19794023
Citation
Armstrong 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 Reference
result
PubMed Identifier
19559969
Citation
Alandejani 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.
Results Reference
result
Learn more about this trial
Manuka Honey Irrigation After Sinus Surgery
We'll reach out to this number within 24 hrs