To determine the effects of early showering after coronary artery bypass graft surgery on wound infection, pain and patient comfort
Design
A clinical trial with a control group, with parallel groups, one-sided blind, randomized, phase 2 on 88 patients. For randomization, block method is done with the help of randomization site.
Settings and conduct
This randomized controlled clinical trial will be conducted in the open heart surgery intensive care unit of Valiasr Faraja Hospital in Tehran in 1402. A written consent form is obtained from the patients who meet the entry requirements, and the intervention protocol is based on the Declaration of Helsinki. Patients are not blinded. The data analyst will not be aware of the allocation of patients to groups.
Participants/Inclusion and exclusion criteria
Age above 18 years; ability to speak Persian; perform CABG through median sternotomy and under cardiopulmonary pump; removal of chest tubes 48 to 72 hours after surgery. Exclusion criteria include cognitive disorders; physical disorders; prolongation of chest tube removal after 72 hours; need to return to the operating room.
Intervention groups
In the intervention group, bathing is done daily from 48 hours after the operation until the time of discharge, and after discharge it is done daily at home. The evaluations are done daily until the time of discharge and the last evaluation is done on the 14th day after the operation. In the control group, according to the hospital routine. Bathing is not done until discharge and the first bath at home is done daily. Assessments are daily until discharge and on the 14th day after surgery.
Main outcome variables
The percentage of wound infection through the operation site infection profile form, the pain score through the visual analog scale, the comfort score through the visual analog scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230917059444N1
Registration date:2023-10-12, 1402/07/20
Registration timing:registered_while_recruiting
Last update:2023-10-12, 1402/07/20
Update count:0
Registration date
2023-10-12, 1402/07/20
Registrant information
Name
Mohsen Safarabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8123 5297
Email address
mohsensafarabadi313@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-11, 1402/07/19
Expected recruitment end date
2024-03-09, 1402/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of early showering after coronary artery bypass graft surgery on wound infection, pain and patient comfort.
Public title
Effects of early showering after coronary artery bypass graft surgery on wound infection, pain and patient comfort.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Ability to speak Persian
Performing CABG through median sternotomy and under cardiopulmonary pump
Removal of chest tubes 48 to 72 hours after surgery
Exclusion criteria:
Cognitive disorders
Physical disorders
Prolonged exit of chest tubes after 72 hours
Need to go back to the operating room
In the data collection process, patients who develop postoperative complications such as cardiac tamponade, pleural effusion, or pneumonia, are transferred to another hospital, or require reoperation will be excluded.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomized into two groups: early shower and late shower. Patients are not blinded. The data analyst will not be aware of the allocation of patients to groups. The selection of samples will be continuous and the allocation of samples to two groups will be done using the website https://www.sealedenvelope.com/.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are not blinded. The data analyst will not be aware of the allocation of patients to groups. The infectious specialist will not be aware of the division of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
At the beginning of Tehran-Qom freeway, in front of Imam Khomeini's shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2023-09-10, 1402/06/19
Ethics committee reference number
IR.SHAHED.REC.1402.080
Health conditions studied
1
Description of health condition studied
Effects of early showering after coronary artery bypass graft surgery on wound infection
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Effects of early showering on pain after coronary artery bypass graft surgery
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Effects of early showering after coronary artery bypass surgery on patient comfort
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people with wound infection
Timepoint
Measurement of wound infection rate 48 hours after surgery and daily before showering until discharge and 14 days after surgery
Method of measurement
The profile of the incidence of surgical site infection
2
Description
Pain score on visual analog scale
Timepoint
Measuring the pain score 48 hours after the operation and daily after showering until discharge and on the 14th day after the operation
Method of measurement
Visual analog scale
3
Description
Patient comfort score on visual analog scale
Timepoint
Measuring the patient's comfort score 48 hours after the operation and daily after taking a shower until discharge and on the 14th day after the operation
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Preparation of culture from the nose to determine the carrier of nasal staphylococcus aureus before the operation, cutting the hair of the operation area and taking a shower before the operation, taking a written consent and completing the demographic information, dressing the wound with sterile gauze after the operation, Removal of chest tubes 48 to 72 hours after the operation by a nurse, performing a chest x-ray to check the possible complications of drain removal (such as pneumothorax) and evaluation by the surgeon, cleaning and disinfection of the bathroom environment by the service personnel, 4 to 6 hours later The wound dressings are removed from the exit of the chest tubes and while the place of exit of the chest tubes is covered with a waterproof dressing (of the same brand for all patients),Take a shower without rubbing or washing the wound strongly, with tap water, the total showering time will be 10 minutes, to maintain safety, patients sit on a chair and use the shower, to prevent hypothermia, the temperature of the bath is between 20 and 23 The temperature is maintained, for each patient, a separate slipper and a clean cover are used to throw on the chair, before going to the bathroom, vital signs and arterial blood oxygen saturation percentage of the patients are controlled, After bathing, do not get up suddenly from the chair, sit in a sitting position for at least 3 minutes, dry the body and the incision site with a sterilized towel, and the patient puts on his clothes, the waterproof dressing is removed from the place where the drains exit and The wound area is covered with antiseptic betadine and then with sterile gauze and straw glue, The wound of the sternotomy area is kept clean and open with betadine, the wound of the graft removal area of the leg (saphenous vein outlet) is left and a varicose sock is worn. It is done up to 72 hours after the operation and then daily before showering. The first assessment of pain and comfort is done 48 to 72 hours after the operation and then daily 30 minutes after showering by the researcher. On the 14th day after the operation, the researcher comes to the clinic and evaluates pain and comfort, and the wound is evaluated for the possible occurrence of signs of infection on the same day in the clinic by an infectious specialist.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Waliasr Faraja Hospital
Full name of responsible person
Mohsen Safarabadi
Street address
Valiasr Hospital Faraja, More than four ways Mirdamad, Valiasr Street
City
Tehran
Province
Tehran
Postal code
19967
Phone
+98 21 8123 5297
Email
mohsensafarabadi313@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Shahriar Bijani
Street address
Valiasr Faraja Hospital, above the Mirdamad intersection, Valiasr Street
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Fax
Email
info@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Mohsen Safarabadi
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street, Above Mirdamad Crossroads, Valiasr Street
City
Tehran
Province
Tehran
Postal code
19967
Phone
+98 21 8123 5297
Fax
Email
mohsensafarabadi313@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Safarabadi
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street, Above Mirdamad Crossroads, Valiasr Street
City
Tehran
Province
Tehran
Postal code
19967
Phone
+98 21 8123 5297
Fax
Email
mohsensafarabadi313@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Safarabadi
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street, Above Mirdamad Crossroads, Valiasr Street
City
Tehran
Province
Tehran
Postal code
19967
Phone
+98 21 8123 5297
Fax
Email
mohsensafarabadi313@gmail.com
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