Effect of topical vancomycin versus placebo on prevention of sinonasal polyposis recurrence after FESS (Functional Endoscopic Sinus Surgery): A triple blinded randomized clinical trial
Objectives: To assess the effect of topical vancomycin versus placebo on prevention of sinonasal polyposis recurrence after FESS
Design: A triple blinded randomized clinical trial
Setting and conduct: The eligible patients with sinonasal polyposis who are candidate for functional endoscopic sinus surgery and will refer to Beasat hospital, in Hamadan City, in 2014
Inclusion criteria: (a) having chronic sinusitis in accordance with polyposis; (b) age of 18 to 70 years.
Exclusion criteria: (a) having immune system disorder; (b) having systemic diseases such as diabetes, chronic renal failure, malignancy, cystic fibrosis, or granolomatosis disease; (c) being pregnant.
Intervention: Standard treatment (including baclofen nasal spray and loratadine tablet) plus nasal irrigation with 20 ml normal saline solution including 1 gr/l vancomycin, three time a day for eight weeks.
Control: Standard treatment (including baclofen nasal spray and loratadine tablet) plus nasal irrigation with 20 ml normal saline solution, three time a day for eight weeks
Primary outcome: Polyposis recurrence in the second, fourth, and sixth months after surgery based on nasal endoscopic criteria.
Secondary outcomes: (a) Staph aureus infection in nasal cavity in the second month after surgery using sterile soap from medial meatus and microbial culture; (b) drug side effects (including nasal dryness and/or sensitivity) 8 weeks after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312299014N20
Registration date:2014-08-16, 1393/05/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-16, 1393/05/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical vancomycin versus placebo on prevention of sinonasal polyposis recurrence after FESS (Functional Endoscopic Sinus Surgery): A triple blinded randomized clinical trial
Public title
Effect of topical vancomycin versus placebo on prevention of sinonasal polyposis recurrence after FESS (Functional Endoscopic Sinus Surgery)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) having chronic sinusitis in accordance with polyposis; (b) age of 18 to 70 years.
Exclusion criteria: (a) having immune system disorder; (b) having systemic diseases such as diabetes, chronic renal failure, malignancy, cystic fibrosis, or granolomatosis disease; (c) being pregnant.
Age
From 15 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan
City
Hamadan
Postal code
6517838695
Approval date
2014-06-17, 1393/03/27
Ethics committee reference number
P/16/35/9/713
Health conditions studied
1
Description of health condition studied
Nasal polyposis
ICD-10 code
J33.0
ICD-10 code description
Polyp of nasal cavity
Primary outcomes
1
Description
Polyposis recurrence
Timepoint
in the second, fourth, and sixth months after surgery
Method of measurement
based on nasal endoscopic criteria
Secondary outcomes
1
Description
Staph aureus infection in nasal cavity
Timepoint
in the second month after surgery
Method of measurement
using sterile soap from medial meatus and microbial culture
2
Description
drug side effects (including nasal dryness and/or sensitivity)
Timepoint
8 weeks after surgery
Method of measurement
Quesytion from patient
Intervention groups
1
Description
Standard treatment (including baclofen nasal spray and loratadine tablet) plus nasal irrigation with 20 ml normal saline solution including 1 gr/l vancomycin, three time a day for eight weeks
Category
Treatment - Drugs
2
Description
Standard treatment (including baclofen nasal spray and loratadine tablet) plus nasal irrigation with 20 ml normal saline solution, three time a day for eight weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat hospital
Full name of responsible person
Dr Javaneh Jahanshahi
Street address
Beasat hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Resident of Ear-Nose-Throat
Full name of responsible person
Dr Javad Yazdani
Position
MD
Other areas of specialty/work
Street address
Beasat hospital, Shahed Square
City
Hamadan
Postal code
Phone
+81 18380090
Fax
Email
hami.yari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Beasat hospital
Full name of responsible person
Dr Javaneh Jahanshahi
Position
Surgeon of Ear-Nose-Throat
Other areas of specialty/work
Street address
Beasat hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 1838 0090
Fax
Email
J.Jahanshahi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)