Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001886279
Ethics application status
Approved
Date submitted
22/07/2016
Date registered
20/11/2018
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Survival of autologous fat transfer (AFT) for scar remodeling with and without platelet rich plasma (PRP)
Scientific title
Outcome of fat survival in scar remodeling with and without use of Activated Platelet Rich Plasma (PRP) in autologous fat transfer: A randomized control Trial
Secondary ID [1] 289724 0
nil
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
scar 299561 0
skin graft 299562 0
Condition category
Condition code
Blood 299532 299532 0 0
Normal development and function of platelets and erythrocytes
Skin 299533 299533 0 0
Other skin conditions
Surgery 299534 299534 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In group A, Fat Graft with PRP will be used. The fat will be harvested by consultant Plastic Surgeon from medial thigh. The procedure will done under local anesthesia. The duration of procedure will be around 60 minutes. The procedure will be done to correct the contour deformity of the patients by filling the fat in different layers of skin and underlying tissue in single procedure. Tumescent or infiltration Solution was made of 0.5% lidocaine with 1:200000 epinephrine diluted in 200 ml lactate ringer solution. This was injected with 17 G cannula in subcutaneous tissue of donor area. The injection and harvesting was done at 2:1. The fat with 23G cannula was harvested and prepared with the help of gravity. The fat separated from fluid and oil.
The PRP will be obtained from the blood of the patient, 20 ml of blood will be obtained by the technician at the start of the procedure before harvesting the fat. The blood will be centrifuge at 1500 revolutions for 5 minutes and then at 2500 revolutions for 10 minutes. The plasma will be separated. 5 cc of adipocytes + 3 ml of PRP in 10 ml syringes with adding 10% CaCl (0.05 cm3 of CaCl per 3 ml).
The extracted fat will be injected with 1cc syringe attached to 14 G needle in multiple layers. 20-30% over correction of contour deformity was done because of chance of absorption. At the end of the procedure, the steri strip over the recipient and dressing for donor sites was applied.
Intervention code [1] 295362 0
Treatment: Surgery
Intervention code [2] 312950 0
Treatment: Other
Comparator / control treatment
In group B, Fat Graft only approach will be used without PRP. The extraction of fat is same PRP and CaCl will not be added.
Control group
Active

Outcomes
Primary outcome [1] 299013 0
Assess the outcome of survival of autologous fat transfer (AFT)) with/without PRP in terms of fat grafting or fat transfer, fat survival.
Timepoint [1] 299013 0
Fat survival will be assessed by pre and 3 months post treatment Ultrasound measurement of the depth of subcutaneous tissue
Secondary outcome [1] 325864 0
Assess the outcome of survival of autologous fat transfer (AFT)) with/without PRP in terms of scar remodeling.
Timepoint [1] 325864 0
Will be assessed by Visual analogue scale at pre and 3 months post treatment.

Eligibility
Key inclusion criteria
At least 2 separate (i.e. non-contiguous) or 1 large wound/scar previously healed by placement of a STSG and/or by secondary intention ("study sites"), each Less than or equal to 80 cm2 in size (area).The sites should be similar in size and anatomical location (e.g. upper arms; trunk; legs) to the extent practically possible.
Adequate adipose available for harvesting
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Life or limb-threatening injury/disease determined on history and clinical examination.
2. Active drug use/abuse determined on history
3. Pregnancy confirmed on urine test.
4. History of bleeding tendency/inability to clot,determined on PT, APTT and/or INR more than or equal to 2.2.
5. Smoking will be assessed on history

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
Sample size calculated from WinPepi version11.15 with significance level of 5 %, 80% power of study ratio of sample size B: A 1 proportion in group a(fat + prp) 69% proportion in group B (fat only) 39 % required sample size is 86, 43 in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/11/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment outside Australia
Country [1] 8044 0
Pakistan
State/province [1] 8044 0
Punjab

Funding & Sponsors
Funding source category [1] 294103 0
Hospital
Name [1] 294103 0
Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan
Country [1] 294103 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Hassan Saeed Khan
Address
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 292939 0
Individual
Name [1] 292939 0
Dr. Farrukh Aslam Khalid
Address [1] 292939 0
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country [1] 292939 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301963 0
Institutional Ethical Review Board
Ethics committee address [1] 301963 0
Ethics committee country [1] 301963 0
Pakistan
Date submitted for ethics approval [1] 301963 0
15/09/2018
Approval date [1] 301963 0
02/11/2018
Ethics approval number [1] 301963 0

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

Contacts
Principal investigator
Name 67590 0
Dr Hassan Saeed Khan
Address 67590 0
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 67590 0
Pakistan
Phone 67590 0
+923329994922
Fax 67590 0
Email 67590 0
[email protected]
Contact person for public queries
Name 67591 0
Hassan Saeed Khan
Address 67591 0
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 67591 0
Pakistan
Phone 67591 0
+923329994922
Fax 67591 0
Email 67591 0
[email protected]
Contact person for scientific queries
Name 67592 0
Hassan Saeed Khan
Address 67592 0
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 67592 0
Pakistan
Phone 67592 0
+923329994922
Fax 67592 0
Email 67592 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.