IRCT | Comparison of the skin effects of pretreatment preparation with chlorhexidine solution and povidone-iodine before rhinoplasty: a randomized clinical trial

Protocol summary

Study aim: Comparison of the skin effects of pretreatment preparation with chlorhexidine solution and povidone-iodine before rhinoplasty
Design: Clinical trial,two interventional group, blinded patients and the assesor, randomization, allocation proportion 1:1 on 42 patients. randomization is doing with exel soft ware RANDBETWEEN.
Settings and conduct: Patients are in two groups includig chlorhexine and povidone-iodine, and prepping 21persons with chlorhexidine and 21 persons with povidone-iodine before surgery. open rhinoplasty surgery is doing by one surgeon in noor surgical clinic. blinding is in two level: patients and the assesor.
Participants/Inclusion and exclusion criteria: Patients who are candidates for rhinoplasty surgery
Intervention groups: First intervention group: prepping the patient's face with chlorhexidine before surgery second intervention group: prepping the patient's face with povidone-iodine before surgery
Main outcome variables: Erythema; Itching

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20211121053135N1

Registration date: 2022-02-06, 1400/11/17

Registration timing: registered_while_recruiting

Last update: 2022-02-06, 1400/11/17

Update count: 0
Registration date: 2022-02-06, 1400/11/17

Registrant information: Name

Hooshyar Abbasi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 83 3729 2254

Email address

hoshyar7ab@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-12-22, 1400/10/01
Expected recruitment end date: 2022-02-20, 1400/12/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the skin effects of pretreatment preparation with chlorhexidine solution and povidone-iodine before rhinoplasty: a randomized clinical trial

Public title: Comparison of the skin effects of pretreatment preparation with chlorhexidine solution and povidone-iodine before rhinoplasty: a randomized clinical trial
Purpose: Other
Inclusion/Exclusion criteria: Inclusion criteria:

ASA I or II health status. The patient is ready to take part in the study and sign the testimonial.

Exclusion criteria:

History of underlying diseases affecting the wound healing process like systemic diseases(diabetes, high blood pressure, gastrointestinal system diseases, kidney disorders, heart and lung diseases) Current consumption of drugs, alcohol, opiums (consumption of any of these substances during the last month) Pregnant women Any allergies or Hypersensitivities to the drugs used in this study
Age: From 18 years old
Gender: Both

Phase

2

Groups that have been masked

Participant
Outcome assessor

Sample size

Target sample size: 42

Randomization (investigator's opinion)

Randomized

Randomization description

Random numbers are generated using Excel software by a statistician to do this. Four-digit codes are generated. A four digit code is allocated to each patient and the last digit on the right indicates the patient group. if the number obtained is odd(1,3,5,7,9), the patient is in the chlorhexidine group and if the number is even(0,2,4,6,8), the patient is in the povidone-iodine group Each of the generated codes is kept separately inside the envelope and the receptionist gives one of these envelopes to the patient before entering the operating room. Accordingly, the next patient code is not predictable. Based on the patient's code, the physician determines which treatments to implement, Only the physician who implements the intervention knows the code allocated to the patient, which after evaluating the outcome, based on thepatient's name, the information collected will be related to the assigned codes.

Blinding (investigator's opinion)

Double blinded

Blinding description

Blinding is performed in 2 levels including the patient and outcome assessor . As the irrigation with chlorhexidine and povidone-iodine is done while anesthesia , the patient is uninformed about the kind of intervention. Also the outcome assessor who is the dermatologist is uninformed about the kind of patients intervention. Therefore in this study both the patient and the outcome assessor are uninformed about the kind of patient intervention.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Kermanshah University of Medical Science

Street address

Mohamadi Ave., Amirkabir Blvd., Kermanshah Town

City

Kermanshah

Province

Kermanshah

Postal code

6714738178
Approval date: 2022-01-29, 1400/11/09
Ethics committee reference number: IR.KUMS.REC.1400.754

Health conditions studied

1

Description of health condition studied: Urticaria
ICD-10 code: L50
ICD-10 code description: Urticaria

2

Description of health condition studied: Erythema
ICD-10 code: B08.3
ICD-10 code description: Erythema infectiosum [fifth disease]

3

Description of health condition studied: Acne
ICD-10 code: L70
ICD-10 code description: Acne

4

Description of health condition studied: Macula
ICD-10 code
ICD-10 code description: Macula

5

Description of health condition studied: Papula
ICD-10 code
ICD-10 code description: Papula

6

Description of health condition studied: Plaque
ICD-10 code
ICD-10 code description: Plaque

7

Description of health condition studied: Seborrheic dermatitis
ICD-10 code: L21
ICD-10 code description: Seborrheic dermatitis

8

Description of health condition studied: Perioral dermatitis
ICD-10 code: L71.0
ICD-10 code description: Perioral dermatitis

9

Description of health condition studied: Allergic contact dermatitis
ICD-10 code: L23
ICD-10 code description: Allergic contact dermatitis

10

Description of health condition studied: Itching
ICD-10 code
ICD-10 code description: Itching

11

Description of health condition studied: Burning
ICD-10 code
ICD-10 code description: Burning

12

Description of health condition studied: Scabbing
ICD-10 code
ICD-10 code description: Scabbing

Primary outcomes

1

Description: Initial outcome will be contain of erythema
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: Erythema will be studied on the basis of dermatologist opinion in this way: without, light, moderate and severe erythema.

2

Description: Initial outcome will be contain of itching
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: Itching will be studied on the basis of ten parts scale Visual Analogue Scale with asking from patient

Secondary outcomes

1

Description: Secondary outcome is containing of burning
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: Burning will be studied on the basis of ten parts scale Visual Analogue Scale with asking from patient

2

Description: Secondary outcome is containing of acne
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events.

3

Description: Secondary outcome is containing of urticaria
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events.

4

Description: Secondary outcome is containing of macula
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events.

5

Description: Secondary outcome is containing of papula
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events.

6

Description: Secondary outcome is containing of allergic contact dermatitis
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events.

7

Description: Secondary outcome is containing of perioral dermatitis
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events.

8

Description: Secondary outcome is containing of seborrheic dermatitis
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events.

9

Description: Secondary outcome is containing of plaque
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events.

10

Description: Secondary outcome is containing of scabbing
Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery.
Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events.

Intervention groups

1

Description: Intervention group (first): in chlorhexidine group, face prepping before surgery is done by 2% chlorhexidine.one surgeon operate them with open method and with midazolam induction, narcotic(fentanyl), atracurium(laxative) and propofol on the basis of person's per kilogram, and the surgery duration is about 1/5 hour and after that all the patients have tampon for 3 days, in addition to they have splint and mesh for one week on their nose.
Category: Prevention

2

Description: Intervention group(second): in povidone-iodine group, face prepping before surgery is done by 10% povidone-iodine. one surgeon operate them with open method and with midazolam induction, narcotic(fentanyl), atracurium(laxative) and propofol on the basis of person's per kilogram, and the surgery duration is about 1/5 hour and after that all the patients have tampon for 3 days, in addition to they have splint and mesh for one week on their nose.
Category: Prevention

Recruitment centers

1

Recruitment center: Name of recruitment center

Noor Specialized Surgical Center

Full name of responsible person

Dr Shahram Abbasabadi

Street address

Azadi Sq, Modares Ave, Kermanshah Town

City

Kermanshah

Province

Kermanshah

Postal code

6714738178

Phone

+98 83 3822 1300

Email

saba.ahmadi.den@gmail.com

Web page address

http://www.noortebclinic.ir

1

Sponsor: Name of organization / entity

Kermanshah University of Medical Sciences

Full name of responsible person

Zohreh Rahimi

Street address

school of dentistry,Shariati Ave

City

Kermanshah

Province

Kermanshah

Postal code

6714738178

Phone

+98 83 3724 8531

Email

saba.ahmadi.den@gmail.com

Web page address

http://dentistry-school.kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Kermanshah University of Medical Science
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Kermanshah University of Medical Sciences

Full name of responsible person

Hoshyar Abbasi

Position

Associated professor

Latest degree

Specialist

Other areas of specialty/work

Dentistry

Street address

Moayed Ave, Sobhan Building

City

Kermanshah

Province

Kermanshah

Postal code

6714738178

Phone

+98 83 3729 2254

Email

hoshyar7ab@yahoo.com

Web page address

http://dentistry-school.kums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Kermanshah University of Medical Sciences

Full name of responsible person

Hoshyar Abbasi

Position

Assiciated professor

Latest degree

Specialist

Other areas of specialty/work

Dentistry

Street address

Moayed Ave, Sobhan Building

City

Kermanshah

Province

Kermanshah

Postal code

6714738178

Phone

+98 83 3729 2254

Email

hoshyar7ab@yahoo.com

Web page address

http://dentistry-school.kums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Kermanshah University of Medical Sciences

Full name of responsible person

Hoshyar Abbasi

Position

Associated professor

Latest degree

Specialist

Other areas of specialty/work

Dentistry

Street address

Moayed Ave,Sobhan Building

City

Kermanshah

Province

Kermanshah

Postal code

6714738178

Phone

+98 83 3729 2254

Email

hoshyar7ab@yahoo.com

Web page address

http://dentistry-school.kums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Comparison of the skin effects of pretreatment preparation with chlorhexidine solution and povidone-iodine before rhinoplasty: a randomized clinical trial