NCT00793117

Brief Summary

Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem. So to solve this problem this research has been designed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

November 15, 2008

Last Update Submit

June 2, 2012

Conditions

EpistaxisNasal ObstructionPain

Keywords

chronic sinusitisFESSpacking

Outcome Measures

Primary Outcomes (1)

  • complication

    6 month

Study Arms (1)

1

EXPERIMENTAL

poly vinil chloride packing

Procedure: packing

Interventions

packingPROCEDURE

packing in middle meatus for duration of 5 day

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with chronic sinusitis who candid of fess

You may not qualify if:

  • Systemic disease
  • Corticosteroid usage counterindication
  • Immune suppresive usage
  • Choncha bollusa resection-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Khomaimee hospital

Tehran, Tehran Province, 19799, Iran

Location

MeSH Terms

Conditions

EpistaxisNasal ObstructionPain

Interventions

Drug Packaging

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsAirway ObstructionRespiratory InsufficiencyRespiration DisordersNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Technology, PharmaceuticalInvestigative TechniquesDrug IndustryManufacturing IndustryIndustryTechnology, Industry, and AgricultureProduct Packaging

Study Officials

  • babak saedi

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate Professor

Study Record Dates

First Submitted

November 15, 2008

First Posted

November 19, 2008

Study Start

November 1, 2008

Primary Completion

October 1, 2009

Study Completion

December 1, 2010

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

IR(1)