Manuka Honey Irrigation After Sinus Surgery

NCT01350193 | Completed Phase 1

• 1 other identifier: MHI-2011
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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."

Conditions

Sinusitis

Keywords

Manuka Honey; Irrigation; Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (2)

• Post-operative endoscopic appearance

  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.

  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

  Participants will be followed for the duration of post op standard of care, an expected average of 6 months.

• Post-operative pain

  Participants will be followed for the duration of post op standard of care, an expected average of 6 months.

Study Arms (2)

Saline Nasal Irrigation

ACTIVE COMPARATOR

Saline Nasal Irrigation is actively being used as the standard of care. It does not contain any active ingredients.

Other: Saline Irrigation

Manuka Honey Irrigation

EXPERIMENTAL

Manuka Honey Irrigation involves the experimental treatment of manuka honey nasal irrigation.

Device: Manuka Honey

Interventions

Manuka Honey DEVICE

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.

Also known as: Irrigation, Endoscopic Sinus Surgery

Manuka Honey Irrigation

Saline Irrigation OTHER

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.

Also known as: Control, Endoscopic Sinus Surgery

Saline Nasal Irrigation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent.
• Adult (over 19 years of age) patients undergoing sinus surgery for chronic rhinosinusitis (CRS) or allergic fungal sinusitis (AFS).

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

ENT Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (4)

• Cooper R. Using honey to inhibit wound pathogens. Nurs Times. 2008 Jan 22-28;104(3):46, 48-9.

  PMID: 18293880 BACKGROUND

• 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.

  PMID: 15125017 RESULT

• 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.

  PMID: 19794023 RESULT

• 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.

  PMID: 19559969 RESULT

MeSH Terms

Conditions

Sinusitis

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Amin R Javer, MD, FRCSC

  St. Paul's Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FRCSC FARS, Principal Investigator, Director of St Paul's Sinus Centre

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 9, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

CA (1)