Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001885280
Ethics application status
Approved
Date submitted
11/11/2018
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
Comparison of graft survival between fat harvested from abdomen and medial thigh for facial contour deformity: a randomized control trial
Scientific title
Comparison of graft survival between fat harvested from abdomen and medial thigh for facial contour deformity: a randomized control trial
Secondary ID [1] 296575 0
nil
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contour deformity 310370 0
Condition category
Condition code
Skin 309095 309095 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The fat will be harvested from medial thigh in Group A by consultant Plastic Surgeon. 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 extracted fat was 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] 312884 0
Treatment: Surgery
Comparator / control treatment
The fat was harvested from medial thigh in Group A and from the abdomen in Group B
Control group
Active

Outcomes
Primary outcome [1] 308063 0
Postoperative high frequency ultrasonography was performed to compare the fat survival by comparing the thickness of the subcutaneous tissue before and after the procedure.
Timepoint [1] 308063 0
At 3 month followup
Secondary outcome [1] 353853 0
bruising of the donor site after fat harvest will be noted by physical examination.
Timepoint [1] 353853 0
at 1 week and 12 week after procedure

Eligibility
Key inclusion criteria
congenital/post Romberg disease/post traumatic facial deformity
Minimum age
10 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
diabetes mellitus, ischemic heart disease, bleeding disorders were excluded from study

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)
by balloting method by researcher. The Ballot with Group numbers was put in a jar and each time when a patient arrives the researcher pick one and assign the group to that patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using balloting
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
Not yet recruiting
Date of first participant enrolment
Anticipated
23/11/2018
Actual
Date of last participant enrolment
Anticipated
28/02/2019
Actual
Date of last data collection
Anticipated
28/05/2019
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment outside Australia
Country [1] 21014 0
Pakistan
State/province [1] 21014 0
Punjab

Funding & Sponsors
Funding source category [1] 301153 0
Hospital
Name [1] 301153 0
Jinnah Burn and Reconstructive Surgery Center
Country [1] 301153 0
Pakistan
Primary sponsor type
Individual
Name
Adbul Malik Mujahid
Address
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 300773 0
None
Name [1] 300773 0
Address [1] 300773 0
Country [1] 300773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301901 0
Institutional Ethical Review Board
Ethics committee address [1] 301901 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Ethics committee country [1] 301901 0
Pakistan
Date submitted for ethics approval [1] 301901 0
15/10/2015
Approval date [1] 301901 0
02/11/2015
Ethics approval number [1] 301901 0

Summary
Brief summary
Fat grafting is an ideal procedure for contour deformity of head and neck after congenital disease or trauma. In this study the fat survival will be checked to confirm which donor site fat survived more. The outcome will be measured by comparing the width of the subcutaneous tissue by ultrasound.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88490 0
Dr Adbul Malik Mujahid
Address 88490 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 88490 0
Pakistan
Phone 88490 0
+023454492128
Fax 88490 0
Email 88490 0
[email protected]
Contact person for public queries
Name 88491 0
Dr Adbul Malik Mujahid
Address 88491 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 88491 0
Pakistan
Phone 88491 0
+023454492128
Fax 88491 0
Email 88491 0
[email protected]
Contact person for scientific queries
Name 88492 0
Dr Adbul Malik Mujahid
Address 88492 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 88492 0
Pakistan
Phone 88492 0
+023454492128
Fax 88492 0
Email 88492 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
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.