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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,
Scientific title
Efficacy of topical steroid in treatment of hyper granulation tissue in burn patients: A randomized control trial
Secondary ID [1] 291712 0
None
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non healing wound 302892 0
Burn 302893 0
Condition category
Condition code
Skin 302379 302379 0 0
Other skin conditions
Injuries and Accidents 302380 302380 0 0
Burns

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 297799 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 301785 0
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
Timepoint [1] 301785 0
weekly till re-epithelialization
Secondary outcome [1] 333866 0
scar hypertrophy (raised Scars) will be examined clinically by the primary researcher at followup
Timepoint [1] 333866 0
3 months after epithelization
Secondary outcome [2] 333867 0
unstable scar (wound breakdown) will be assessed from history and examination of the patient by primary researcher.
Timepoint [2] 333867 0
3 months after epithelization

Eligibility
Key inclusion criteria
Non healing wound < 5 cm(square) in burn patients due to split skin graft loss
Minimum age
13 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sepsis
Culture positive wounds
Pregnancy
Patients is on steroids (immunocompromised)

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)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization with mixing the envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
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.

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] 8824 0
Pakistan
State/province [1] 8824 0
Punjab

Funding & Sponsors
Funding source category [1] 296213 0
Hospital
Name [1] 296213 0
Jinnah Burn and Reconstructive Surgery Centre
Address [1] 296213 0
Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country [1] 296213 0
Pakistan
Primary sponsor type
Individual
Name
Farrukh Aslam Khalid
Address
Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 295122 0
Individual
Name [1] 295122 0
Zain ul Abidin
Address [1] 295122 0
Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country [1] 295122 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297452 0
Jinnah Burn and Reconstructive Surgery Centre Ethical Review Board
Ethics committee address [1] 297452 0
Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Ethics committee country [1] 297452 0
Pakistan
Date submitted for ethics approval [1] 297452 0
01/04/2017
Approval date [1] 297452 0
05/05/2017
Ethics approval number [1] 297452 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49058 0
Dr Farrukh Aslam Khalid
Address 49058 0
Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 49058 0
Pakistan
Phone 49058 0
+923009671600
Fax 49058 0
Email 49058 0
drfarrukhaslam@gmail.com
Contact person for public queries
Name 49059 0
Dr Farrukh Aslam Khalid
Address 49059 0
Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 49059 0
Pakistan
Phone 49059 0
+923009671600
Fax 49059 0
Email 49059 0
drfarrukhaslam@gmail.com
Contact person for scientific queries
Name 49060 0
Dr Farrukh Aslam Khalid
Address 49060 0
Jinnah Burn and Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 49060 0
Pakistan
Phone 49060 0
+923009671600
Fax 49060 0
Email 49060 0
drfarrukhaslam@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary