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Trial registered on ANZCTR


Registration number
ACTRN12618001632280
Ethics application status
Approved
Date submitted
16/09/2018
Date registered
3/10/2018
Date last updated
20/01/2020
Date data sharing statement initially provided
20/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of outcome with amnion versus Alginate for skin graft donor site dressing.
Scientific title
Comparison of outcome of amnion versus alginate for skin graft donor site dressing; a randomized control trial
Secondary ID [1] 296093 0
NIL
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin graft donor site wound 309669 0
Condition category
Condition code
Skin 308471 308471 0 0
Other skin conditions
Surgery 308472 308472 0 0
Other surgery

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.
A single sheet of graft would be harvested with Zimmer dermatome, graft width of 4 inches, with the thickness of 0.010 inches. After harvesting the graft, the donor site would be covered with adrenaline-soaked gauze for 2 minutes to secure hemostasis. 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 donor site by the primary investigator, ensuring no air bubbles between it and the bed. Secondary dressing with gauze and crepe bandage will be done. The amnion will remain there till wound healing is achieved by epithelization. Will be followed up to atleast 2 weeks and up to 1 month.
Intervention code [1] 312433 0
Treatment: Other
Comparator / control treatment
Alginate dressing (Kaltostat-ConvaTec) 10x20 cm will be applied after drying the donor site. Secondary dressing with gauze and crepe bandage will be done
Control group
Active

Outcomes
Primary outcome [1] 307454 0
Wound healing by complete epithelization assessed clinically by seeing the complete resurfacing of skin by epithelium.
Timepoint [1] 307454 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] 351943 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] 351943 0
It will be assessed on post operative days 1, 5 and 10
Secondary outcome [2] 351944 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] 351944 0
Assessed on post operative days 1, 5 and 10.
Secondary outcome [3] 351945 0
Hypertrophic scarring, donor sites will be assessed at 6 months for hyperpigmentation, erythema and raised scarring based on the following scoring:
1. Normal: Flat and soft scar of normal skin pigmentation( colour)
2. Mildly hypertrophic: Slightly elevated, moderately hard, light to dark pink color
3. Hypertrophic: Elevated within wound margins, hard, dark pink to dark red in color
4. Keloid: Very elevated, extending beyond wound margins, very hard, red to brown in color.
Timepoint [3] 351945 0
at post operative 6 months.
Secondary outcome [4] 351946 0
Number of dressings changes by reviewing the medical records
Timepoint [4] 351946 0
Soakage of dressing with exudate would be noted and number of secondary dressing changes done recorded till wound epithelization uptill 1 month.

Eligibility
Key inclusion criteria
Candidates of Split-thickness skin graft harvested with Zimmer dermatome with the thickness of 0.010 inches and width of 4 inches, single sheet (20-30 cm), harvested from right or left thigh
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with allergy to Alginate or any of the other products used determined on history and examination
2. Immunocompromised patients- with systemic infection determined on clinical examination.
3. Patients with serious and uncontrolled co-morbidities: diabetes, hypertension, ischemic heart disease determined on history and clinical examination.
4. Pregnant and lactating females.
5. Burn patients.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
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
15/10/2018
Date of last participant enrolment
Anticipated
Actual
11/05/2019
Date of last data collection
Anticipated
Actual
22/11/2019
Sample size
Target
48
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 20849 0
Pakistan
State/province [1] 20849 0
Punjab

Funding & Sponsors
Funding source category [1] 300681 0
Hospital
Name [1] 300681 0
Jinnah Burn and Reconstructive Surgery Center
Country [1] 300681 0
Pakistan
Primary sponsor type
Individual
Name
Roeya-E-Rasul
Address
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 300210 0
None
Name [1] 300210 0
Address [1] 300210 0
Country [1] 300210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301463 0
Institutional Ethical Review Board
Ethics committee address [1] 301463 0
Ethics committee country [1] 301463 0
Pakistan
Date submitted for ethics approval [1] 301463 0
06/08/2018
Approval date [1] 301463 0
04/09/2018
Ethics approval number [1] 301463 0
4595/ED/JB&RSC

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

Contacts
Principal investigator
Name 87094 0
Dr Roeya-E-Rasul
Address 87094 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 87094 0
Pakistan
Phone 87094 0
+923028467282
Fax 87094 0
Email 87094 0
rerasul@yahoo.com
Contact person for public queries
Name 87095 0
Farrukh Aslam Khalid
Address 87095 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 87095 0
Pakistan
Phone 87095 0
+923009671600
Fax 87095 0
Email 87095 0
drfarrukhaslam@gmail.com
Contact person for scientific queries
Name 87096 0
Farrukh Aslam Khalid
Address 87096 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 87096 0
Pakistan
Phone 87096 0
+923009671600
Fax 87096 0
Email 87096 0
drfarrukhaslam@gmail.com

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?

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.