Manuka Honey Irrigation After Sinus Surgery
Palavras-chave
Resumo
Descrição
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.
datas
| Última verificação: | 11/30/2013 |
| Enviado pela primeira vez: | 05/02/2011 |
| Inscrição estimada enviada: | 05/05/2011 |
| Postado pela primeira vez: | 05/08/2011 |
| Última atualização enviada: | 12/01/2013 |
| Última atualização postada: | 12/03/2013 |
| Data real de início do estudo: | 05/31/2011 |
| Data Estimada de Conclusão Primária: | 12/31/2012 |
| Data Estimada de Conclusão do Estudo: | 03/31/2013 |
Condição ou doença
Intervenção / tratamento
Device: Manuka Honey Irrigation
Other: Saline Nasal Irrigation
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| 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 Nasal 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. |
| Experimental: Manuka Honey Irrigation Manuka Honey Irrigation involves the experimental treatment of manuka honey nasal irrigation. | Device: Manuka Honey 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. |
Critério de eleição
| Idades qualificadas para estudar | 19 Years Para 19 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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 |
Resultado
Medidas de Resultado Primário
1. Post-operative endoscopic appearance [Participants will be followed for the duration of post op standard of care, an expected average of 6 months.]
2. Post-Operative SNOT-22 [Participants will be followed for the duration of post op standard of care, an expected average of 6 months.]
Medidas de Resultado Secundário
1. Post-operative bleeding [Participants will be followed for the duration of post op standard of care, an expected average of 6 months.]
2. Post-operative pain [Participants will be followed for the duration of post op standard of care, an expected average of 6 months.]
