Protocol summary

Summary
The purpose of this study was to compare the results of septorhinoplasty surgery in patients with and without tampon.This is a prospective clinical trial in patients undergoing septorhinoplasty in 2015 at Amiralmomenin Hospital. Seventy Subjects with the age range of 18-50 years of both sexes were included in the study. Exclusion criteria of our study are patients with underlying disease (such as diabetes, heart problems, high blood pressure, and blood dyscrasia), a history of nasal polyps, drug abuse, nasal allergy, blood-thinning drugs such as aspirin. Patients with a history of nasal septum and turbinate surgery, curved nasal deformity, perforated septum, saddle-shaped deformity excluded Informed consent of the patients will be taken. The patients will be divided into two groups of with and without tampon. 35 patients underwent septorhinoplasty with packing in Time Period 1 and 35 patients underwent septorhinoplasty without packing in Time Period 2, Each Time Period is one Month. During septum surgery, both groups will be sewn with yarn 3 0 vicryl. Suture running will be performed by the surgeon.Mesh treated with tetracycline will be administrated in the tampon-using group. Tampons will be removed after 48 hours.Related outcomes in the short term, medium term and long term in bothgroups will be checked.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201507051138N21
Registration date: 2015-08-21, 1394/05/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-21, 1394/05/30
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Science, Vice Chancellor for Resarch
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study Septorhinoplasty With and Without Nasal Packing in Operated patients
Public title
Septorhinoplasty With and Without Nasal Packing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:18-50 years; exclusion criteria: patients with underlying disease (such as diabetes, heart problems, high blood pressure, and blood dyscrasia); a history of nasal polyps; drug abuse; nasal allergy; blood-thinning drugs such as aspirin; Patients with a history of nasal septum and turbinate surgery; nasal deformity curved; perforated septum; saddle-shaped deformity;
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Tehran avenue
City
Rasht
Postal code
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
IR.GUMS.REC.1394.78

Health conditions studied

1

Description of health condition studied
Septorhinoplasty
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Ecchymosis
Timepoint
Two days after surgery
Method of measurement
Based on clinical examination

2

Description
Bleeding
Timepoint
Two days after surgery,One week after surgery,One Month after surgery
Method of measurement
Based on clinical examination

3

Description
Patient satisfaction
Timepoint
Two days after surgery,One week after surgery,One Month after surgery
Method of measurement
Based on clinical examination

4

Description
Edema
Timepoint
Two days after surgery
Method of measurement
Based on clinical examination

5

Description
Hematoma
Timepoint
Two days after surgery
Method of measurement
Based on clinical examination

6

Description
Mucosal lesions
Timepoint
One week after surgery
Method of measurement
Based on clinical examination

7

Description
Difficulty breathing
Timepoint
One week after surgery
Method of measurement
Based on clinical examination

8

Description
Pain
Timepoint
, One week after surgery
Method of measurement
Based on clinical examination

9

Description
Secondary infection
Timepoint
One week after surgery,One Month after surgery
Method of measurement
Based on clinical examination

10

Description
Granuloma
Timepoint
One week after surgery
Method of measurement
Based on clinical examination

11

Description
Mucosal Adhesion in Nasal Airway
Timepoint
One Month after surgery
Method of measurement
Based on clinical examination

12

Description
Nasal valve stenosis
Timepoint
One week after surgery
Method of measurement
Based on clinical examination

13

Description
Marginal incision site
Timepoint
One Month after surgery
Method of measurement
Based on clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
35 patients underwent septorhinoplasty with packing in Time Period 1, septum will be sewn with yarn 3 0 vicryl. Suture running will be performed by the surgeon.Mesh treated with tetracycline will be administrated in the tampon-using group. Tampons will be removed after 48 hours.
Category
Treatment - Surgery

2

Description
35 patients underwent septorhinoplasty without packing in Time Period 2, Each Time Period is one Month. During septum surgery, septum will be sewn with yarn 3 0 vicryl. Suture running will be performed by the surgeon.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralamomenin Hospital
Full name of responsible person
Street address
Amiralamomenin Hospital, 17 shahrivar St
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Science, Vice Chancellor for Resarch
Full name of responsible person
Susan Komaee
Street address
Gas Square, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Science, Vice Chancellor for Resarch
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
Guilan University of Medical Science
Full name of responsible person
Dr Ali Faghih habibi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amiralamomenin Hospital, 17 shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
Dr.faghih.habibi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Ali Faghih habibi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amiralamomenin Hospital, 17 shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
Dr.faghih.habibi@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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