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NCT00793117 Clinical Trial

The Effect of Packing in Post Operative Management of FESS

Pain Clinical Trial

Official title:
The Evaluation of Effect of Pva Sponge in Prevention of Complications in Fess

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00793117
Other study ID # BS-87-01-48-6841
Secondary ID 87-01-48-6844
Status Completed
Phase Phase 4
First received November 15, 2008
Last updated June 2, 2012
Start date November 2008
Est. completion date December 2010

Study information
Verified date June 2012
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.

Description:

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.

Someone claimed packing is unnecessary and other one propose different material to packing after surgery. So to solve this problem this research has been designed.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date December 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with chronic sinusitis who candid of fess

Exclusion Criteria:

- Systemic disease

- Corticosteroid usage counterindication

- Immune suppresive usage

- Choncha bollusa resection-

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• packing
packing in middle meatus for duration of 5 day

Locations
Country Name City State
Iran, Islamic Republic of Imam Khomaimee hospital Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary complication 6 month Yes
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