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Trial registered on ANZCTR


Registration number
ACTRN12620000058976
Ethics application status
Approved
Date submitted
12/11/2019
Date registered
24/01/2020
Date last updated
3/03/2022
Date data sharing statement initially provided
24/01/2020
Date results information initially provided
3/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of antibiotics vs no antibiotics after incision and drainage of simple subcutaneous abscesses in children
Scientific title
Comparison of antibiotics vs no antibiotics after incision and drainage of simple subcutaneous abscesses in children
Secondary ID [1] 299788 0
none
Universal Trial Number (UTN)
U1111-1242-4850
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
simple subcutaneous abscess 315157 0
Condition category
Condition code
Surgery 313477 313477 0 0
Other surgery
Skin 313831 313831 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this interventional group No postoperative antibiotics will be given , after incision and drainage of simple subcutaneous abscesses .
Intervention code [1] 316046 0
Treatment: Drugs
Comparator / control treatment
in this study , the regular post-operative antibiotics Are given after incision and drainage of simple subcutaneous abcesses. In this group amoxicillin and clavulanic acid will be used as postoperative antibiotics, 30-50mg/kg given orally thrice a day for 3-5 days . . For MRSA,detected on culture and senstivity clindamycin 25-40mg/kg/day in three divided doses Intravenous or 35-40mg/kg/day in four divided doses
Control group
Active

Outcomes
Primary outcome [1] 321944 0
recurrence of abscesses after primary treatment of incision and drainage. recurrence of abcsesses will be checked clinically .
Timepoint [1] 321944 0
30 days post-operative
Secondary outcome [1] 376764 0
clinical cure of abscesses. it will be checked clinically when there will be no discharge from wound, no symptoms of fever or tachycardia and healed wound.
Timepoint [1] 376764 0
1, 14 and 30 days post-operative

Eligibility
Key inclusion criteria
all patients with simple subcutaneous abscesses.
Minimum age
1 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with any generalized debilitating disease, malnourished, immunocompromised, diabetic or using steroids.
2. Having any systemic illness or more than one abscess on body.
3. Allergy to routinely used antibiotic.
4. Any break in anti-septic technique.
5. Whose parents refuse to be part of study.
6. Area of induration of more than 5cm.
7. Perineal, perianal and paronychial abscesses

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 randomization using coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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 recurrence and cure in both groups will be presented as frequency and percentages. P-value = 0.05 will be considered as significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2020
Actual
1/02/2020
Date of last participant enrolment
Anticipated
10/11/2020
Actual
1/06/2021
Date of last data collection
Anticipated
20/12/2020
Actual
14/06/2021
Sample size
Target
150
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 22104 0
Pakistan
State/province [1] 22104 0
Punjab

Funding & Sponsors
Funding source category [1] 304252 0
Self funded/Unfunded
Name [1] 304252 0
Fatima Majeed
Country [1] 304252 0
Pakistan
Primary sponsor type
Individual
Name
Fatima Majeed
Address
The Children's Hospital and The Institute of Child's Health , Ferozepur Road Lahore, 54600, punjab
Country
Pakistan
Secondary sponsor category [1] 304494 0
None
Name [1] 304494 0
none
Address [1] 304494 0
none
Country [1] 304494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304708 0
The Children's Hospital and The Institute of Child's Health ,Lahore Pakistan
Ethics committee address [1] 304708 0
The Children's Hospital and The Institute of Child's Health, Ferozpur Road Lahore. 54600,Punjab
Ethics committee country [1] 304708 0
Pakistan
Date submitted for ethics approval [1] 304708 0
15/05/2019
Approval date [1] 304708 0
25/07/2019
Ethics approval number [1] 304708 0

Summary
Brief summary
The objective of the study is to compare cure rate and recurrence in children undergoing incision and drainage of simple subcutaneous abscesses with and without postoperative antibiotic .
HYPOTHESIS;
The effect of antibiotics vs no antibiotics post-operatively Is same , along with wound wash and daily dressings for cure of simple subcutaneous abscesses in children undergoing incision and drainage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97946 0
Dr Fatima Majeed
Address 97946 0
The Children's Hospital and The Institute of Child's Health , Ferozepur Road Lahore..54600 Punjab
Country 97946 0
Pakistan
Phone 97946 0
+923154402201
Fax 97946 0
Email 97946 0
[email protected]
Contact person for public queries
Name 97947 0
Fatima Majeed
Address 97947 0
The Children's Hospital and The Institute of Child's Health , Ferozepur Road Lahore,54600 Punjab
Country 97947 0
Pakistan
Phone 97947 0
+923154402201
Fax 97947 0
Email 97947 0
[email protected]
Contact person for scientific queries
Name 97948 0
Fatima Majeed
Address 97948 0
The Children's Hospital and The Institute of Child's Health , Ferozepur Road Lahore,54600, Punjab
Country 97948 0
Pakistan
Phone 97948 0
+923154402201
Fax 97948 0
Email 97948 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 378722-(Uploaded-27-02-2022-08-11-01)-Basic results summary.docx
Plain language summaryNo after incision and drainage of simple subcutaneous... [More Details]

Documents added automatically
No additional documents have been identified.