Manuka Honey Irrigation After Sinus Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01350193
First received: May 3, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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."


Condition Intervention Phase
Sinusitis
Device: Manuka Honey
Other: Saline Irrigation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Manuka Honey Irrigation After Endoscopic Sinus Surgery

Resource links provided by NLM:


Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months. ] [ Designated as safety issue: No ]
  • Post-operative pain [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months. ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: June 2011
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saline Nasal Irrigation
Saline Nasal Irrigation is actively being used as the standard of care. It does not contain any active ingredients.
Other: Saline Irrigation
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.
Other Names:
  • Saline Irrigation
  • Control
  • Endoscopic Sinus Surgery
Experimental: Manuka Honey Irrigation
Manuka Honey Irrigation involves the experimental treatment of manuka honey nasal irrigation.
Device: Manuka Honey
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.
Other Names:
  • Manuka Honey
  • Irrigation
  • Endoscopic Sinus Surgery

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350193

Locations
Canada, British Columbia
ENT Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
Principal Investigator: Amin R Javer, MD, FRCSC St. Paul's Hospital, Canada
  More Information

Publications:
Responsible Party: Amin Javer, MD FRCSC FARS, Principal Investigator, Director of St Paul's Sinus Centre, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT01350193     History of Changes
Other Study ID Numbers: MHI-2011
Study First Received: May 3, 2011
Last Updated: December 2, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Paul's Hospital, Canada:
Manuka Honey
Irrigation
Endoscopic Sinus Surgery

ClinicalTrials.gov processed this record on October 19, 2014