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Trial registered on ANZCTR


Registration number
ACTRN12625000199415
Ethics application status
Approved
Date submitted
18/11/2024
Date registered
20/02/2025
Date last updated
20/02/2025
Date data sharing statement initially provided
20/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcomes of meningomyelocele repair with or without platelet rich plasma application
Scientific title
Outcomes of meningomyelocele repair with or without platelet rich plasma application in patients with meningomyelocele
Secondary ID [1] 313396 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
meningomyelocele 335762 0
Condition category
Condition code
Neurological 332320 332320 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To compare outcome of meningomyelocele repair with or without platelet rich plasma in terms of preventing cerebrospinal fluid leakage, meningitis and wound infection.

During meningomyelocele repair, a neural plate was formed and watertight dural closure was done. After achieving hemostasis, Platelet rich plasma was applied over dural repair and wound edges.
b) Platelet rich plasma will be obtained by centrifugation at 200 g at 22 degree celcius for 10 minutes. Then uppermost layer will again be transferred into another centrifugation tube by using sterile pipette and this will again centrifugate at 400g at 22 degree celcius . Around 1ml of Platelet rich plasma will be obtained by this two step method. All this will be done pre operatively to save time.
c) Surgeon will do the intervention.
d) Intervention requires fifteen to thirty minutes.
e) Direct observation of the surgery is required to assess adherence to surgery
Intervention code [1] 329973 0
Treatment: Surgery
Comparator / control treatment
Control group was meningomyelocele repair without platelet rich plasma , in this group a neural plate was formed and watertight dural closure was done without applying platelet rich plasma over it.
Control group
Active

Outcomes
Primary outcome [1] 339898 0
Cerebrospinal fluid leakage
Timepoint [1] 339898 0
after 24 hours post operatively
Primary outcome [2] 339899 0
meningitis
Timepoint [2] 339899 0
after 24 hours post operatively
Secondary outcome [1] 441861 0
wound infection
Timepoint [1] 441861 0
after 4th post operative day
Secondary outcome [2] 441862 0
wound dehiscence
Timepoint [2] 441862 0
after 4th post operative day

Eligibility
Key inclusion criteria
Patients with meningomyelocele of both genders and age between 2 days to 1 years.
Minimum age
2 Days
Maximum age
1 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients presenting with meningitis.
Patients presenting with sepsis.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size of 70 patients (35 in each group) is estimated by using 95% confidence level, 10% absolute precision with expected percentage of leakage with PRP as 0% and without PRP 10% . ( pilot study) Chi square test was used to analyse qualitative independent data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 26736 0
Pakistan
State/province [1] 26736 0
Punjab

Funding & Sponsors
Funding source category [1] 317838 0
Self funded/Unfunded
Name [1] 317838 0
Country [1] 317838 0
Primary sponsor type
Individual
Name
Dr Mahwish Noor ul haq
Address
Country
Pakistan
Secondary sponsor category [1] 320168 0
None
Name [1] 320168 0
Address [1] 320168 0
Country [1] 320168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316520 0
Institutional review board king Edward medical university nila gumbad new anar Kali Lahore Pakistan
Ethics committee address [1] 316520 0
92-4299214819
Ethics committee country [1] 316520 0
Pakistan
Date submitted for ethics approval [1] 316520 0
31/05/2024
Approval date [1] 316520 0
13/07/2024
Ethics approval number [1] 316520 0

Summary
Brief summary
During meningomyelocele repair, a neural plate was formed and watertight dural closure is done. After achieving hemostasis, platelet rich plasma was applied over dural repair and wound edges. Study purpose is to compare outcome of meningomyelocele repair with or without platelet rich plasma in terms of preventing CSF leakage, meningitis and wound dehiscence.
Hypothesis: Platelet rich plasma during meningomyelocele repair prevent cerebrospinal fluid leakage, promotes healing and reduce mortality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138142 0
Ms Dr Mahwish Noor ul haq
Address 138142 0
Mayo hospital , Anarkali bazaar Lahore, Punjab 54000
Country 138142 0
Pakistan
Phone 138142 0
+923045334860
Fax 138142 0
Email 138142 0
Contact person for public queries
Name 138143 0
Dr Mahwish Noor ul haq
Address 138143 0
Mayo hospital, Anarkali bazaar Lahore, Punjab 54000
Country 138143 0
Pakistan
Phone 138143 0
+923045334860
Fax 138143 0
Email 138143 0
Contact person for scientific queries
Name 138144 0
Dr Mahwish Noor ul haq
Address 138144 0
Mayo hospital, Anarkali bazaar Lahore, Punjab 54000
Country 138144 0
Pakistan
Phone 138144 0
+923045334860
Fax 138144 0
Email 138144 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24347Ethical approval    388771-(Uploaded-21-12-2024-22-01-48)-ethical approval mmc.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.