Protocol summary
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Study aim
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comparison of the effects of hydrogen peroxide and normal saline irrigation on postoperative complications of rhinoplasty in patients undergoing rhinoplasty
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Design
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In this In this study, which is a randomized single-blinded clinical trial, volunteers of rhinoplasty who entered the study with informed written consent were randomly divided into intervention and control groups, and the severity of the complications of both groups at specified intervals after ending of the Surgery is monitored to evaluate the effect of hydrogen peroxide on the prevention of these complications.
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Settings and conduct
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The present study is a single-blind clinical trial conducted at Arya Hospital of Kermanshah affiliated to Kermanshah University of Medical Sciences. Patients are blind to the type of intervention they will receive.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients undergoing rhinoplasty right after the operation.
Non inclusion criteria: opioid, drug and alcohol abusers; History of previous or present systemic diseases and continuous use of drugs; daily use of analgesics or using of them 24 hours before the operation; patients who can not cooperate
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Intervention groups
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Rinoplasty volunteers who enter this study with written consent are randomly divided into normal saline and hydrogen peroxide groups. Immediately after surgery, and before dressing, in the intervention group, the position is washed with 3% hydrogen peroxide and in the control group the position is washed with normal saline.
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Main outcome variables
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The severity of pain, swelling, edema, ecchymosis, bleeding, inflammation and infection
General information
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Reason for update
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Modification of some scales and methods that have been done during the study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140503017537N6
Registration date:
2019-02-03, 1397/11/14
Registration timing:
prospective
Last update:
2021-12-01, 1400/09/10
Update count:
1
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Registration date
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2019-02-03, 1397/11/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-05, 1397/12/14
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Expected recruitment end date
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2019-08-05, 1398/05/14
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Actual recruitment start date
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2019-03-11, 1397/12/20
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Actual recruitment end date
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2019-09-11, 1398/06/20
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Trial completion date
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2019-11-01, 1398/08/10
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Scientific title
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Comparison of the effects of hydrogen peroxide and normal saline irrigation on postoperative complications of rhinoplasty in patients undergoing rhinoplasty
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Public title
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The effects of hydrogen peroxide irrigation on postoperative complications of rhinoplasty
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients undergoing rhinoplasty right after the operation
Exclusion criteria:
Opioid, drug and alcohol abusers
History of previous or present systemic diseases and continuous use of drugs
daily use of analgesics or using them 24 hours before the operation
Patients who can not cooperate
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
44
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A random number generation technique will be used in the Excel environment, so that a code is assigned to each patient before starting the study using the random numbers table. Depending on the last digit of the assigned code, the type of treatment being selected. If the last digit of the code is even ( 0, 2, 4, 6, 8) the patient is placed in the hydrogen peroxide group, and if it is odd, the patient is placed in the control group. By this method, allocation of each patient to the hydrogen peroxide group or normal saline group is accomplished by simple randomization technique
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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A secretary who has no role in the study assigns a code to each patient using the random code table. These codes that identify the patient group are sealed and closed until the completion of the study in an envelope. Therefore, random allocation and allocation concealment is achieved for both the patients as well as the operators, examiners, surgeons and clinicians.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-26, 1397/10/05
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Ethics committee reference number
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IR.KUMS.REC.1397.745
Health conditions studied
1
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Description of health condition studied
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postoperative complications of rhinoplasty
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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severity of postoperative pain
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Timepoint
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At intervals 2, 6, 12 to 24 hours after surgery
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Method of measurement
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using the Visual Analogue Scale(VAS)
2
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Description
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severity of postoperative swelling
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Timepoint
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At intervals of 1 week, 2 weeks, 4 weeks and 8 weeks after surgery
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Method of measurement
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using the Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE)
3
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Description
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severity of postoperative edema
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Timepoint
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On days 1,2,5,7,10 after surgery
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Method of measurement
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using the Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE)
4
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Description
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severity of postoperative echymosis
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Timepoint
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On days 1,2,5,7,10 after surgery
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Method of measurement
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using the Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE)
5
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Description
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amount of postoperative bleeding
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Timepoint
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On the first day after surgery
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Method of measurement
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Counting the number of dressing needed
6
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Description
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severity of postoperative inflammation
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Timepoint
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During the first week after surgery
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Method of measurement
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using the +-
7
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Description
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severity of postoperative infection
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Timepoint
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During the first week after surgery
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Method of measurement
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using the +-
Intervention groups
1
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Description
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Intervention group: After the operation has finished, before dressing the wound , the surgical field is washed with hydrogen peroxide (3%) (which is made immediately before the process and kept in good condition away from light).
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Category
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Treatment - Drugs
2
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Description
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Control group: After the operation has finished, before dressing the wound , the surgical field is washed with normal saline.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There are no further information available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available