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Effect of topical vancomycin versus placebo on prevention of sinonasal polyposis recurrence after FESS (Functional Endoscopic Sinus Surgery)

Effect of topical vancomycin versus placebo on prevention of sinonasal polyposis recurrence after FESS (Functional Endoscopic Sinus Surgery): A triple blinded randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201312299014N20
Enrollment
36
Registered
2014-08-16
Start date
2014-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal polyposis. Polyp of nasal cavity

Interventions

Intervention 1: 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 eigh
Treatment - Drugs
Placebo
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
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

Sponsors

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 70 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Polyposis recurrence. Timepoint: in the second, fourth, and sixth months after surgery. Method of measurement: based on nasal endoscopic criteria.

Secondary

MeasureTime frame
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.;Drug side effects (including nasal dryness and/or sensitivity). Timepoint: 8 weeks after surgery. Method of measurement: Quesytion from patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Javad Yazdani

Resident of Ear-Nose-Throat

hami.yari@yahoo.com+81 18380090

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026