Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000934145
Ethics application status
Approved
Date submitted
31/05/2019
Date registered
4/07/2019
Date last updated
4/07/2019
Date data sharing statement initially provided
4/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
success rate of suprafacial and subfacial anterolateral thigh flap in terms of survival
Scientific title
Comparison of flap outcome in terms of flap survival in Supra-facial and Sub-facial anterolateral Thigh Flap for soft tissue reconstruction: A Randomized Control Trial
Secondary ID [1] 298380 0
Nil
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft tissue reconstruction 313056 0
Free tissue transfer 313057 0
Condition category
Condition code
Surgery 311551 311551 0 0
Surgical techniques
Skin 311552 311552 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Soft tissue reconstruction which requires free tissue transfer will be selected. Wound will be prepared with debrima or tumor resection and recipient vessels will be prepared by the surgical team. The Suprafacial anterolateral thigh flap will be marked according to the wound size, perforators will be marked with the help of hand held doppler. The flap will be raised supra facial, perforators will be identified and then a cuff of facial will be taken around the perforator. Dissection will be done to identify the donor vessels. once the required length of vessels achieved the flap will be divided, insetting and anastomosis will be done by the surgical team with one or two Plastic surgeons leading the team. The flap raising will be done in around 2 hours time. Donor site will be closed primarily or with split skin graft.
Intervention code [1] 314623 0
Treatment: Surgery
Comparator / control treatment
In Group B, the dissection of the flap will be subfacial and the steps of the surgery will be the same.
Control group
Active

Outcomes
Primary outcome [1] 320261 0
Flap survival is defined as survival of the skin paddle of the flap. It will be assessed clinically by the Consultant Plastic Surgeon by examining the flap skin for complete survival of skin paddle, partial survival or flap failure
Timepoint [1] 320261 0
2 weeks after surgery
Secondary outcome [1] 371017 0
Dysesthesia ( discomfort or pain from touch to the skin by normal stimuli including clothing) will be assessed on history by consultant plastic surgeon and will be marked as yes or no on the proforma.
Timepoint [1] 371017 0
at 3 months of followup
Secondary outcome [2] 371018 0
Numbness ( loss of sensation at the donor site) will be assessed on history and examination by consultant plastic surgeon and will be marked as yes or no on the proforma.
Timepoint [2] 371018 0
at 3 months of followup
Secondary outcome [3] 371019 0
Paresthesia ( presence tingling, tickling pricking or burning at the donor site without any physical cause) will be assessed on history by consultant plastic surgeon and will be marked as yes or no on the proforma.
Timepoint [3] 371019 0
at 3 months of followup

Eligibility
Key inclusion criteria
Patients with soft tissue defects due to trauma or cancer ablation which requires a free tissue for reconstruction.
Minimum age
15 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with history of diabetes mellitus (FBS>110 mg/dl on presentation).
• Patients with vascular or penetrating injury
• Patients who lost to follow

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)
balloting method using sealed opaque envelop by primary surgeon
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table
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
10/07/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 21538 0
Pakistan
State/province [1] 21538 0
Punjab

Funding & Sponsors
Funding source category [1] 302917 0
Hospital
Name [1] 302917 0
Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan
Country [1] 302917 0
Pakistan
Primary sponsor type
Individual
Name
Farrukh Aslam Khalid
Address
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 302879 0
None
Name [1] 302879 0
Address [1] 302879 0
Country [1] 302879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303487 0
Institutional Ethical Review Board
Ethics committee address [1] 303487 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Ethics committee country [1] 303487 0
Pakistan
Date submitted for ethics approval [1] 303487 0
15/01/2018
Approval date [1] 303487 0
01/02/2018
Ethics approval number [1] 303487 0

Summary
Brief summary
The study is to compare the outcome of the two surgical techniques to raise the anterolateral thigh flap. The primary outcome of study is survival and the secondary outcomes are dysesthesia, numbness and paraestehsia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93826 0
Dr Farrukh Aslam Khalid
Address 93826 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 93826 0
Pakistan
Phone 93826 0
+923009671600
Fax 93826 0
Email 93826 0
[email protected]
Contact person for public queries
Name 93827 0
Dr Farrukh Aslam Khalid
Address 93827 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 93827 0
Pakistan
Phone 93827 0
+923009671600
Fax 93827 0
Email 93827 0
[email protected]
Contact person for scientific queries
Name 93828 0
Dr Farrukh Aslam Khalid
Address 93828 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 93828 0
Pakistan
Phone 93828 0
+923009671600
Fax 93828 0
Email 93828 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.