Efficacy of Mupirocin Ointment into Nostril on polyposis reccurence Following Functional endoscopic sinus surgery (FESS) in Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)
Investigating the effect of using mupirocin ointment into nostrils of chronic rhinosinusitis with nasal polyposis patients in reducing the recurrence of polyps after functional endoscopic sinus surgery
Design
Double-blind case-controlled clinical trial among 24 Caucasian patients with Chronic rhinosinusitis with nasal polyps (CRSwNP) who underwent sinus surgery between 2020-2021 and followed for 6 months
Settings and conduct
24 patients with Chronic Rhinosinusitis with Nasal Polyposis and a positive nostrils culture for Staphylococcus aureus who had been referred for sinus surgery to the Firoozgar general hospital and Rasool general Hospital, Tehran, Iran, between 2020-2022. The right nostril in each patient was determined as the intervention group (applying mupirocin ointment) and the left nostril as the control group (applying vitamin A ointment). Lund-Mackay radiological scores and Lund-Kennedy endoscopic scores were examined at the time of diagnosis and 6 months after ointment usage
Participants/Inclusion and exclusion criteria
Patients with Chronic Rhinosinusitis with nasal polyposis (CRSwNP) candidated for surgery with positive cultures from both nostrils for Staphylococcus aureus and their Lund Mackay (LM) and Lund Kennedy (LK) scores were almost same at both sides of the nose and sinuses were included; Nasal polyposis due to neoplasm, autoimmune diseases, Fungal sinusitis and ect except CRSwNP and patients with LM scores and LK scores were significantly different at both sides of the nose and sinuses were excluded
Intervention groups
In each patient the right nostril was determined as the intervention group (applying mupirocin ointment) and the left nostril as the control group (applying vitamin A ointment)
Main outcome variables
Nasal nostril mupirocin ointment usage can not reduce polyp reccurence after sinus surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221013056165N1
Registration date:2024-05-05, 1403/02/16
Registration timing:retrospective
Last update:2024-05-05, 1403/02/16
Update count:0
Registration date
2024-05-05, 1403/02/16
Registrant information
Name
Maryam Mohsenian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2670 7158
Email address
mmohsenian1987@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2021-09-22, 1400/06/31
Trial completion date
2022-03-21, 1401/01/01
Scientific title
Efficacy of Mupirocin Ointment into Nostril on polyposis reccurence Following Functional endoscopic sinus surgery (FESS) in Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)
Public title
Mupirocin ointment effect on Polyposis recurrence after Sinus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with CRSwNP candidate for surgery
Lund-Mackay scores and Lund-kennedy scores were almost same at both sides of the nose and sinuses
Exclusion criteria:
Nasal polyposis due to neoplasm, autoimmune diseases, Fungal rhinosinusitis and ect except Chronic Rhinosinusitis with Nasal Polyposis
Patients with Lund-Mackay and Lund-Kennedy scores were significantly different at both sides of the nose and sinuses
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
22
More than 1 sample in each individual
Number of samples in each individual:
2
Positive culture for Staphylococcus aureus from nasal nostril swab samples from both sides of the nose
Actual sample size reached:
24
More than 1 sample in each individual
Actual sample size in each individual:
2
Positive culture for Staphylococcus aureus from nasal nostril swab samples from both sides of the nose
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in the study did not know about the difference in the effect of the two types of ointment
Outcome evaluator was not aware of the study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnics committee of iran university of medical sciences
Street address
Research and Technology Vice-Chancellor, Central Headquarters Building, Iran University of Medical Sciences, Hemat Hwy. , Next to Milad tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-07-14, 1399/04/24
Ethics committee reference number
IR.IUMS.FMD.REC.1399.290
Health conditions studied
1
Description of health condition studied
Chronic Rhinosinusitis with Nasal Polyposis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
Lund Mackay radiologic score
Timepoint
At the beginning of the study (before the start of the intervention), 6 months after using the ointment
Method of measurement
Lund Mackay radiologic scoring system
2
Description
Lund Kennedy endoscopic score
Timepoint
At the beginning of the study (before the start of the intervention), 6 months after using the ointment
Method of measurement
Lund Kennedy endoscopic scoring system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mupirocin-Najo 2%, topical ointment -made by Iran Najo pharmaceutical company, Tehran, Iran- was prescribed twice daily for six months from the time of primary surgery until the follow-up endoscopy into the right nostril
Category
Treatment - Drugs
2
Description
Control group: Xerovit (vitamin A), sterile ophthalmic ointment 25000 IU -made by Sina Darou Laboratories Company, Tehran, Iran- was prescribed twice daily for six months from the time of primary surgery until the follow-up endoscopy into the left nostril
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Maryam Mohsenian
Street address
Rasoul akram Hospital., Niayesh St., Sattarkhan St.