Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000400965
Ethics application status
Approved
Date submitted
11/12/2019
Date registered
25/03/2020
Date last updated
16/07/2021
Date data sharing statement initially provided
25/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are prophylactic antibiotics still required for inguinal herniotomy in children?

Scientific title
Are prophylactic antibiotics still required for inguinal herniotomy in children?
Secondary ID [1] 300054 0
none
Universal Trial Number (UTN)
U1111-1245-1948
Trial acronym
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
inguinal hernia 315566 0
Condition category
Condition code
Surgery 313861 313861 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this interventional group No pre-operative and postoperative antibiotics will be given after herniotomy of children with inguinal hernia.
Intervention code [1] 316326 0
Treatment: Surgery
Intervention code [2] 316797 0
Treatment: Other
Comparator / control treatment
in this study, control group will be given pre-operative and post-operative antibiotics .. Patients in this group will be given Ceftriaxone 50-100mg/kg intravenously as a single dose at the time of induction of anesthesia and post-operatively amoxicillin/clavulanic acid 30-50mg/kg/day per oral in three divided doses for 3-5 days.
.
Control group
Active

Outcomes
Primary outcome [1] 322248 0
condition of wound using southampton wound scoring system
0 normal healing
1 normal healing with slight bruising or erythema
2 erythema plus other signs of inflammation
3 clear or hemoserous discharge
4 major complication like pus
5 deep or severe wound infection with or without breakdown, hematoma requiring aspiration
Timepoint [1] 322248 0
1 day post surgery
Secondary outcome [1] 377868 0
it will be checked clinically by looking at the condition of wound , and scoring will be done according to southampton scoring system which is as follows

score condition of wound
0 normal healing
1 normal healing with mild bruising and erythema
2 erythema plus other signs of inflammation
3 clear or hemoserous discharge
4 major complication like pus
5 deep or sever wound infection with or without breakdown , or hematoma requiring aspiration
Timepoint [1] 377868 0
day 7 and 14 post discharge

Eligibility
Key inclusion criteria
all patients with inguinal hernia between age group of 1-13 years .
Minimum age
1 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with any generalized debilitating disease.
• Any infective focus in the body /on the skin.
• Poor quality of the skin or ongoing infection at the incision site.
• Allergy to routinely used antibiotic.
• History of use of antibiotics within past 7 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis
The collected data will be entered and analyzed accordingly using SPSS version 22 through its statistical program. Mean ± SD will be calculated for age of the patients. Chi-square test will be applied. Qualitative variables like gender and number of patients developing wound infection in both groups will be presented as frequency and percentages. P-value = 0.05 will be considered as significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/05/2019
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
14/10/2021
Actual
Sample size
Target
200
Accrual to date
100
Final
Recruitment outside Australia
Country [1] 22177 0
Pakistan
State/province [1] 22177 0
Punjab

Funding & Sponsors
Funding source category [1] 304506 0
Hospital
Name [1] 304506 0
The Children’s Hospital and the Institute of Child’s Health
Country [1] 304506 0
Pakistan
Primary sponsor type
Individual
Name
Fatima Majeed
Address
The Children's Hospital and The Institute of Child'e Health , Ferozepur road Lahore, 54600 Punjab
Country
Pakistan
Secondary sponsor category [1] 304775 0
None
Name [1] 304775 0
none
Address [1] 304775 0
none
Country [1] 304775 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304937 0
The Children's Hospital and The Institute of Child's Health ,Lahore Pakistan
Ethics committee address [1] 304937 0
The Children's Hospital and The Institute of Child's Health , Ferozepur Road ,54600 Lahore Punjab
Ethics committee country [1] 304937 0
Pakistan
Date submitted for ethics approval [1] 304937 0
10/04/2019
Approval date [1] 304937 0
20/04/2019
Ethics approval number [1] 304937 0

Summary
Brief summary
The objective of the study is to compare surgical site infection rate in children undergoing inguinal herniotomy with and without antibiotic prophylaxis.
Hypothesis:
no prophylactic antibiotic is required for surgical site infection in children, undergoing inguinal herniotomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98694 0
Dr Fatima Majeed
Address 98694 0
The Children's Hospital and The Institute of Child's Health , Ferozepur Road Lahore, 54600 Punjab
Country 98694 0
Pakistan
Phone 98694 0
+923154402201
Fax 98694 0
Email 98694 0
[email protected]
Contact person for public queries
Name 98695 0
Dr Fatima Majeed
Address 98695 0
The Children's Hospital and The Institute of Child's Health , Ferozepur Road Lahore, 54600 Punjab
Country 98695 0
Pakistan
Phone 98695 0
+923154402201
Fax 98695 0
Email 98695 0
[email protected]
Contact person for scientific queries
Name 98696 0
Dr Fatima Majeed
Address 98696 0
The Children's Hospital and The Institute of Child's Health , Ferozepur Road Lahore, 54600 Punjab
Country 98696 0
Pakistan
Phone 98696 0
+923154402201
Fax 98696 0
Email 98696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all de-identified data of participants included in study , in form of data sheets
When will data be available (start and end dates)?
immediately after publication for 3 years
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator Dr. Fatima Majeed at following email address: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3877Basic resultsNo 378909-(Uploaded-29-06-2022-01-36-23)-Basic results summary.docx
4141Plain language summaryNo are prophylactic antibiotics still required for in... [More Details]

Documents added automatically
No additional documents have been identified.