Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001631291
Ethics application status
Approved
Date submitted
19/09/2018
Date registered
3/10/2018
Date last updated
18/06/2019
Date data sharing statement initially provided
18/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the terms of mean healing time of amnion versus conventional antimicrobial ointment alone in facial burn patients.
Scientific title
Comparison of the outcome (in terms of mean healing time) of amnion versus conventional antimicrobial ointment alone in facial burn patients: a randomized control trial.
Secondary ID [1] 296115 0
Nil
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn 309694 0
Condition category
Condition code
Skin 308498 308498 0 0
Other skin conditions
Injuries and Accidents 308499 308499 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Amnion will be obtained after informed consent from enrolled healthy expecting mothers undergoing C-section, with no co-morbidities or infections, testing negative for HBV, HCV and HIV. Meconium-contaminated placenta would be discarded. Amnion will be separated from placenta by washing with large volumes of normal saline. Membranes would then be transferred to another container containing 70% glycerol and refrigerated at 4 degree Centigrade.
For Group A, Amnion will be retrieved from the fridge, dipped in normal saline for 10 min to remove glycerol and applied to the cleaned and dried facial burns by the primary investigator, ensuring no air bubbles between it and the bed. Topical antibiotic onitment (Polyax Ointment - Glaxosmithkline) will be applied three times a day upto 2 atleast 2 weeks upto 1 month. No secondary dressing will be applied. The amnion will remain there till the burn wound epithelization atleast 2 weeks and up to 1 month.
Intervention code [1] 312445 0
Treatment: Other
Comparator / control treatment
In group B, only topical antibiotic onitment (Polyax Ointment - Glaxosmithkline) will be applied uni formally over the wound as a thin layer, three times a day till wound healing for atleast 2 weeks and upto 1 month.
Control group
Active

Outcomes
Primary outcome [1] 307488 0
Wound healing by complete epithelization assessed clinically by seeing the complete resurfacing of skin by epithelium.
Timepoint [1] 307488 0
Patients will be assessed on post-operative day 1, 5, and 10. Finally, the post-operative day on which the dressing spontaneously leaves the donor site, revealing a healed wound, will be noted up to 1 month
Secondary outcome [1] 352061 0
Pain, Scored numerically by asking the patient to grade the pain on a scale of 1 to 10. 1 being the lowest, 10 being the highest
Timepoint [1] 352061 0
It will be assessed on post operative days 1, 5 and 10
Secondary outcome [2] 352062 0
Wound infection, will be assessed clinically by the researcher as presence of erythema of surrounding skin, excessive and foul-smelling discharge, fever with no other source of infection, and a positive culture.
Timepoint [2] 352062 0
Assessed on post operative days 1, 5 and 10.

Eligibility
Key inclusion criteria
1. All patients with partial thickness facial burns (as per-operational definition).
2. Duration of burn <72 hours
Minimum age
10 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. TBSA <11% and >40%.
2. Patients with full thickness burns as assessed clinically

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 involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a random number table from a statistic book
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/10/2018
Actual
8/10/2018
Date of last participant enrolment
Anticipated
Actual
1/03/2019
Date of last data collection
Anticipated
Actual
1/05/2019
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 20855 0
Pakistan
State/province [1] 20855 0
Punjab

Funding & Sponsors
Funding source category [1] 300704 0
Hospital
Name [1] 300704 0
Jinnah Burn and Reconstructive Surgery Center
Country [1] 300704 0
Pakistan
Primary sponsor type
Individual
Name
Muhammad Umar Asif
Address
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 300237 0
None
Name [1] 300237 0
Address [1] 300237 0
Country [1] 300237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301488 0
Institutional Ethical Review Board
Ethics committee address [1] 301488 0
Ethics committee country [1] 301488 0
Pakistan
Date submitted for ethics approval [1] 301488 0
10/08/2018
Approval date [1] 301488 0
04/09/2018
Ethics approval number [1] 301488 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87166 0
Dr Muhammad Umar Asif
Address 87166 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 87166 0
Pakistan
Phone 87166 0
+923006162008
Fax 87166 0
Email 87166 0
[email protected]
Contact person for public queries
Name 87167 0
Farrukh Aslam Khalid
Address 87167 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 87167 0
Pakistan
Phone 87167 0
+923009671600
Fax 87167 0
Email 87167 0
[email protected]
Contact person for scientific queries
Name 87168 0
Farrukh Aslam Khalid
Address 87168 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 87168 0
Pakistan
Phone 87168 0
+923009671600
Fax 87168 0
Email 87168 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The trial has no website. Data will be stored confidentially and will not be used for any further research unless further ethics approval is granted.


What supporting documents are/will be available?

No Supporting Document Provided



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.