Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000030178
Ethics application status
Approved
Date submitted
6/01/2019
Date registered
11/01/2019
Date last updated
11/01/2019
Date data sharing statement initially provided
11/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcome of split thickness skin graft over scalp wound with and without using vacuum assisted closure dressing
Scientific title
Outcome of split thickness skin graft over scalp wound with or without vacuum assisted closure in terms of graft take
Secondary ID [1] 296974 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 310933 0
Scalp wound 310934 0
Vacuum assisted closure 310935 0
Condition category
Condition code
Skin 309599 309599 0 0
Other skin conditions
Surgery 309600 309600 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The scalp wound will be debrided under general anesthesia and split skin graft harvested by the primary surgeon from thigh of the patient with the dermatome. It will be meshed with 1:1.5 mesher board and will be fixed over the wound with the skin staplers. The group A patient will have Vacuum assisted closure (VAC) of the wound and will be attached with the VAC machine at 50 mm Hg continuous suction pressure. The dressing will remain there for four days and then graft will be inspected by the primary surgeon. Graft will be dressed again with conventional dressing of Paraffin gauze and secondary dressing. Patient will be discharged on day 6 after second dressing change.
Intervention code [1] 313244 0
Treatment: Surgery
Comparator / control treatment
The group B patients will have skin grafted and fixation of the graft with staples but will be dressed with conventional paraffin gauze and secondary dressing. rest of the protocols will be the same.
Control group
Active

Outcomes
Primary outcome [1] 318561 0
Graft take will be assessed clinically by consultant plastic surgeon
Timepoint [1] 318561 0
3 weeks after surgery
Secondary outcome [1] 365378 0
Graft loss will be assessed clinically by consultant plastic surgeon
Timepoint [1] 365378 0
At 3 weeks after skin grafting
Secondary outcome [2] 365379 0
Seroma will be assessed clinically by consultant Plastic Surgeon
Timepoint [2] 365379 0
At first dressing change on day 4th post-operative
Secondary outcome [3] 365380 0
Haematoma will be assessed clinically by consultant Plastic Surgeon
Timepoint [3] 365380 0
At first dressing change on day 4th post-operative

Eligibility
Key inclusion criteria
Scalp wound > 6cm
Post traumatic, Post burn and Post surgery wounds
Minimum age
5 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with polytruama, Hypertension and Diabetes mellitus

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 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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2019
Actual
Date of last participant enrolment
Anticipated
31/05/2019
Actual
Date of last data collection
Anticipated
1/08/2019
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 21162 0
Pakistan
State/province [1] 21162 0
Punjab

Funding & Sponsors
Funding source category [1] 301547 0
Hospital
Name [1] 301547 0
Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan
Country [1] 301547 0
Pakistan
Primary sponsor type
Individual
Name
Noor Ali Kakar
Address
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 301245 0
Individual
Name [1] 301245 0
Dr. Farrukh Aslam Khalid
Address [1] 301245 0
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country [1] 301245 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302281 0
Institutional Ethical Review Board
Ethics committee address [1] 302281 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Ethics committee country [1] 302281 0
Pakistan
Date submitted for ethics approval [1] 302281 0
01/05/2017
Approval date [1] 302281 0
01/06/2017
Ethics approval number [1] 302281 0

Summary
Brief summary
Split thickness graft is a standard procedure for scalp wounds. The possible complications of seroma and haematoma leads to graft failure or partial graft loss. Vacuum assisted closure has improved skin graft take in different studies. We want to compare the results of graft take with or without Vacuum assisted closure over the scalp.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89678 0
Dr Noor Ali Kakar
Address 89678 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 89678 0
Pakistan
Phone 89678 0
+923337811546
Fax 89678 0
Email 89678 0
[email protected]
Contact person for public queries
Name 89679 0
Dr Farrukh Aslam Khalid
Address 89679 0
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 89679 0
Pakistan
Phone 89679 0
+923009671600
Fax 89679 0
Email 89679 0
[email protected]
Contact person for scientific queries
Name 89680 0
Dr Farrukh Aslam Khalid
Address 89680 0
Jinnah Burn and Reconstructive Surgery Centre,
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 89680 0
Pakistan
Phone 89680 0
+923009671600
Fax 89680 0
Email 89680 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.