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Trial registered on ANZCTR
Registration number
ACTRN12617001058369
Ethics application status
Approved
Date submitted
16/04/2017
Date registered
19/07/2017
Date last updated
30/01/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparative study of outcome of Topical steroid application compared with traditional dressing for non healing wound in burn patients,
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Scientific title
Efficacy of topical steroid in treatment of hyper granulation tissue in burn patients: A randomized control trial
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Secondary ID [1]
291712
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None
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Universal Trial Number (UTN)
U1111-1131-0755
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non healing wound
302892
0
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Burn
302893
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Condition category
Condition code
Skin
302379
302379
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0
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Other skin conditions
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Injuries and Accidents
302380
302380
0
0
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Burns
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In Group A we will apply Topical 1% Hydrocortisone (Fusidin-H cream) thinly smeared once daily with 4x4 inch gauze piece onto wound bed by the dresser. Primary researcher will follow the patient for intervention adherence and will note in data. During the dressing changes, routine digital photographs will be taken. Duration of treatment will be till the wound healed (epithelialized). Time to complete wound healing will be noted and defined as the number of days from application of steroid until complete epithelialization.
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Intervention code [1]
297799
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Treatment: Drugs
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Comparator / control treatment
In Group B we will apply liquid paraffin gauze (Bactigras) onto wound bed by the dresser. Primary researcher will follow the patient for intervention adherence and will note in data. During the dressing changes, routine digital photographs will be taken. Duration of treatment will be till the wound healed (epithelialized). Time to complete wound healing will be noted and defined as the number of days from application of steroid until complete epithelialization.
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Control group
Active
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Outcomes
Primary outcome [1]
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The formation of granulation tissue into an open wound allows the re-epithelialization phase to take place, as epithelial cells migrate across the new tissue to form a barrier between the wound and the environment and will be assessed by two different consultants by photographs. and the time of re-epithelialization will be noted by each
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Assessment method [1]
301785
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Timepoint [1]
301785
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weekly till re-epithelialization
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Secondary outcome [1]
333866
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scar hypertrophy (raised Scars) will be examined clinically by the primary researcher at followup
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Assessment method [1]
333866
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Timepoint [1]
333866
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3 months after epithelization
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Secondary outcome [2]
333867
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unstable scar (wound breakdown) will be assessed from history and examination of the patient by primary researcher.
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Assessment method [2]
333867
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Timepoint [2]
333867
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3 months after epithelization
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Eligibility
Key inclusion criteria
Non healing wound < 5 cm(square) in burn patients due to split skin graft loss
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Minimum age
13
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Sepsis
Culture positive wounds
Pregnancy
Patients is on steroids (immunocompromised)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelope
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization with mixing the envelopes
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The collected data will be entered and analyzed by using SPSS version 20. Mean and standard deviation will be calculated for numerical variables like age, TBSA%, modified baux score. Frequency and percentage will be calculated for categorical variables like gender, scar hypertrophy ( yes/No), unstable scar ( yes/No ),efficacy (yes/no).Paired sample t test will b applied to see the effect on efficacy with p value = 0.05 will be considered as significant.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
24/07/2017
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Date of last participant enrolment
Anticipated
31/07/2017
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Actual
14/10/2017
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Date of last data collection
Anticipated
30/09/2017
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Actual
6/01/2018
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Sample size
Target
32
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Accrual to date
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Final
32
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Recruitment outside Australia
Country [1]
8824
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Pakistan
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State/province [1]
8824
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Punjab
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Funding & Sponsors
Funding source category [1]
296213
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Hospital
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Name [1]
296213
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Jinnah Burn and Reconstructive Surgery Centre
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Address [1]
296213
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Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Country [1]
296213
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Pakistan
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Primary sponsor type
Individual
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Name
Farrukh Aslam Khalid
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Address
Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Country
Pakistan
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Secondary sponsor category [1]
295122
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Individual
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Name [1]
295122
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Zain ul Abidin
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Address [1]
295122
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Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Country [1]
295122
0
Pakistan
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297452
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Jinnah Burn and Reconstructive Surgery Centre Ethical Review Board
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Ethics committee address [1]
297452
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Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Ethics committee country [1]
297452
0
Pakistan
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Date submitted for ethics approval [1]
297452
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01/04/2017
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Approval date [1]
297452
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05/05/2017
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Ethics approval number [1]
297452
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Summary
Brief summary
After getting approval from the ethical committee of our hospital .Total 32 patients who fulfill our inclusion criteria will be enrolled in our study. An inform consent will be taken from each patient. All cases will underwent surgical debridement and split thickness skin grafting.
We will randomized select the patients into two groups with secondarily graft loss area less than 5cm2 by lottery method.
In Group A, we will apply Topical 1% Hydrocortisone (Fusidin-H cream) and Group B will be managed with Medicated Paraffin gauze (bactigrass) dressing. Steroid will be applied topically thinly smeared once daily with 4x4 inch gauze piece onto wound bed. We will observe and access the wound weekly with visual and photographic evaluation that will be done by two consultant plastic surgeons. During the dressing changes, routine digital photographs will be taken with the signed consent of the patient/guardian for the purposes of treatment, teaching and use in academic publications.
Time to complete wound healing was noted and defined as the number of days from application of steroid until epithelialization. Percentage of total body surface area burned, sex, age, burn mechanism, complications (burning skin, dry skin, and itching, increased hair growth at application site) and presence of hyper granulation tissue were assessed and correlated with time to complete wound healing.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
49058
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Dr Farrukh Aslam Khalid
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Address
49058
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Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Country
49058
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Pakistan
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Phone
49058
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+923009671600
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Fax
49058
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Email
49058
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[email protected]
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Contact person for public queries
Name
49059
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Dr Farrukh Aslam Khalid
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Address
49059
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Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Country
49059
0
Pakistan
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Phone
49059
0
+923009671600
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Fax
49059
0
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Email
49059
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[email protected]
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Contact person for scientific queries
Name
49060
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Dr Farrukh Aslam Khalid
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Address
49060
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Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Country
49060
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Pakistan
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Phone
49060
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+923009671600
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Fax
49060
0
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Email
49060
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[email protected]
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No information has been provided regarding IPD availability
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.
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