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Trial registered on ANZCTR


Registration number
ACTRN12621000569808
Ethics application status
Approved
Date submitted
23/08/2020
Date registered
17/05/2021
Date last updated
17/05/2021
Date data sharing statement initially provided
17/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized Controlled Trial: Comparison of One-Per-Mil Tumescent Technique and Tourniquet in Surgery for Post-Burn Hand Contracture in Creating Clear Operative Field and Assessment of Final Functional Outcome
Scientific title
A Randomized Controlled Trial: Comparison of One-Per-Mil Tumescent Technique and Tourniquet in Surgery for Post-Burn Hand Contracture in Creating Clear Operative Field and Assessment of Final Functional Outcome
Secondary ID [1] 302079 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postburn hand contracture 318687 0
Condition category
Condition code
Surgery 316698 316698 0 0
Surgical techniques
Injuries and Accidents 319453 319453 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One-per-mil tumescent technique.
Before the surgery begins, the subjects in one-per-mil tumescent group will be injected subcutaneously with one-per-mil tumescent solution which consists of 1:1,000,000 epinephrine and lidocaine 0.2% in saline solution (NaCl 0.9%). The solution will be injected into the surgical sites using 26G needle and 1 mL syringe until the skin blanches (becomes pale). Single surgeon (principal investigator) will perform all the procedures. The injection will be given one time only, 25 minutes prior to first incision. The amount of injected solution will be recorded in the case report form.
Intervention code [1] 318377 0
Treatment: Surgery
Comparator / control treatment
Pneumatic tourniquet application
The cuff of pneumatic tourniquet will be inflated in the upper arm of respective hand directly before the first incision and the pressure of 125 mmHg will be given to stop the blood flow. After two hours (120 minutes), the tourniquet will be deflated and removed. If further inflation is needed (i.e. the surgery has not finished yet), 15-minute waiting time will be performed before the second inflation. The duration of the tourniquet application will be recorded in the case report form.
Control group
Active

Outcomes
Primary outcome [1] 324832 0
The clarity of operative field.
Timepoint [1] 324832 0
The surgery will be video-recorded and three independent assessors will assess the clarity of operative field through the surgery video. The assessors will evaluate the first 15 minutes of the surgery continuously. It is continued by evaluating the first 10-minute of each hour of the surgery (every 10 minutes for each hour of surgery). All of the timepoints are accounted for the assessment.
Primary outcome [2] 324833 0
- Total active movement of the hand assessed using goniometer
Timepoint [2] 324833 0
At least 3 months postoperatively
Primary outcome [3] 327145 0
Total passive movement of the hand assessed using goniometer
Timepoint [3] 327145 0
At least 3 months postoperatively
Secondary outcome [1] 385881 0
Serum malondialdehyde level
Timepoint [1] 385881 0
In one-per-mil tumescent group:
- 5 minutes before tumescent injection
- 25 minutes after the last tumescent injection
- 60 minutes after the last tumescent injection

In tourniquet group:
- 5 minutes before tourniquet inflation
- 1 minute before tourniquet release
- 10 minutes after tourniquet release
Secondary outcome [2] 385882 0
Serum tumor necrosis factor alpha level
Timepoint [2] 385882 0
In one-per-mil tumescent group:
- 5 minutes before tumescent injection
- 25 minutes after the last tumescent injection
- 60 minutes after the last tumescent injection

In tourniquet group:
- 5 minutes before tourniquet inflation
- 1 minute before tourniquet release
- 10 minutes after tourniquet release
Secondary outcome [3] 385883 0
Blood gas analysis of venous blood which composes of pH, PO2, PCO2, HCO3, and base excess
Timepoint [3] 385883 0
In one-per-mil tumescent group:
- 5 minutes before tumescent injection
- 25 minutes after the last tumescent injection
- 60 minutes after the last tumescent injection

In tourniquet group:
- 5 minutes before tourniquet inflation
- 1 minute before tourniquet release
- 10 minutes after tourniquet release

Eligibility
Key inclusion criteria
- Patients aged 5-65 years, who are otherwise healthy, with post-burn hand deformity who will undergo contracture release in Cipto Mangunkusumo Hospital, Jakarta, Indonesia
- Patients who give informed consent to participate in the research
Minimum age
5 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with hematologic disorders, peripheral vascular disorders, diabetes mellitus, hypertension, liver diseases, and rheumatic diseases
- Patients who are smoking except those who are willing to stop the smoking habit for at least two weeks before surgery
- Patients who consume anti-coagulant or anti-thrombotic medications, such as heparin, aspirin, clopidogrel, and warfarin

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We use the sample size calculator provided by Open Source Epidemiologic Statistics for Public Health (www.openepi.com) to calculate sample size for unmatched cross-sectional and cohort studies, including clinical trials.
Two-sided confidence level (1-alpha) = 95%
Power (1-beta, % chance of detecting) = 99%
Ratio of Unexposed to Exposed in sample = 1.0 (for equal sample)
Percent of Unexposed with Outcome = 99% (proportion of tourniquet to create bloodless operative field was 99%)
Percent of Exposed with Outcome = 29% (proportion of one-per-mil tumescent technique to create bloodless operative field was 29% based on previous research)

Based on this calculator, the sample size needed for this study is 36 participants.

Data processing and analysis will be carried out using Microsoft Excel (Microsoft, Redmond, US) and SPSS (IBM, Armonk, US).

Patient characteristics will be analyzed using independent samples t-test for normally distributed numerical data or the Mann-Whitney test for those that are not normally distributed; and the Chi square test for normally distributed nominal data or the Fisher's Exact Test for those that are not normally distributed.

Meanwhile, the final result: the clarity of operative field will be compared using the Chi square test if the data is normally distributed and if all the expected frequency values of each group are equal to or greater than five. If the data obtained are not normally distributed or the sample size is small so that the frequency value in one group is less than five, the Fisher's Exact Test is used.

To compare means of postoperative function with ROM and examination of biological markers, namely malondialdehyde, tumor necrosis factor-alpha, and venous blood gas analysis, independent samples t-test (for normally distributed data) or the Mann-Whitney test (for data that were not normally distributed) will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/08/2016
Date of last participant enrolment
Anticipated
Actual
17/05/2018
Date of last data collection
Anticipated
Actual
31/08/2018
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 22868 0
Indonesia
State/province [1] 22868 0
DKI Jakarta

Funding & Sponsors
Funding source category [1] 306498 0
Hospital
Name [1] 306498 0
Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Country [1] 306498 0
Indonesia
Primary sponsor type
Individual
Name
Theddeus Octavianus Hari Prasetyono, MD, PhD
Address
Division of Plastic Surgery, Department of Surgery, Cipto Mangunkusumo Hospital/Faculty of Medicine Universitas Indonesia
Jalan Diponegoro No. 71, Central Jakarta, 10430, Indonesia
Country
Indonesia
Secondary sponsor category [1] 307025 0
Individual
Name [1] 307025 0
Patricia Marcellina Sadikin, MD
Address [1] 307025 0
Division of Plastic Surgery, Department of Surgery, Cipto Mangunkusumo Hospital/Faculty of Medicine Universitas Indonesia
Jalan Diponegoro No. 71, Central Jakarta, 10430, Indonesia
Country [1] 307025 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306703 0
Health Research Ethical Committee of the Faculty of Medicine Universitas Indonesia
Ethics committee address [1] 306703 0
Jalan Salemba Raya No. 6, Jakarta 10430
Ethics committee country [1] 306703 0
Indonesia
Date submitted for ethics approval [1] 306703 0
25/05/2015
Approval date [1] 306703 0
27/07/2015
Ethics approval number [1] 306703 0
No. 600/UN2.F1/ETIK/2015

Summary
Brief summary
This study aims to compare the clarity of operative field and final functional outcome created by non-tourniquet technique using one-per-mil tumescent technique and pneumatic tourniquet in postburn hand contracture surgery.
In this study, the subjects will be randomly allocated into two groups; one-per-mil tumescent group and tourniquet group. Both group will undergo similar contracture release surgery, except the surgery preparation to stop or reduce the bleeding conducted at the beginning of the surgery. One group will be prepared using one-per-mil tumescent technique. The surgery sites will be injected with one-per-mil tumescent solution which consists of epinephrine (vasoconstrictive agent), lidocaine (analgetic agent), and normal saline until the skin turns pale. The other group will be prepared using tourniquet.

It is expected that one-per-mil tumescent technique is as effective as tourniquet to create clear operative field in postburn hand contracture surgery and eventually the final functional outcome in both groups will be similar.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104726 0
Dr Theddeus Octavianus Hari Prasetyono
Address 104726 0
Cipto Mangunkusumo Hospital/Universitas Indonesia
Jalan Diponegoro No. 71, Central Jakarta 10430, DKI Jakarta, Indonesia
Country 104726 0
Indonesia
Phone 104726 0
+62817858899
Fax 104726 0
+622131931424
Email 104726 0
[email protected]
Contact person for public queries
Name 104727 0
Theddeus Octavianus Hari Prasetyono
Address 104727 0
Cipto Mangunkusumo Hospital/Universitas Indonesia
Jalan Diponegoro No. 71, Central Jakarta 10430, DKI Jakarta, Indonesia
Country 104727 0
Indonesia
Phone 104727 0
+62817858899
Fax 104727 0
+622131931424
Email 104727 0
[email protected]
Contact person for scientific queries
Name 104728 0
Theddeus Octavianus Hari Prasetyono
Address 104728 0
Cipto Mangunkusumo Hospital/Universitas Indonesia
Jalan Diponegoro No. 71, Central Jakarta 10430, DKI Jakarta, Indonesia
Country 104728 0
Indonesia
Phone 104728 0
+62817858899
Fax 104728 0
+622131931424
Email 104728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subjects to approvals by Principal Investigator (email: [email protected] or mobile phone number: +62817858899)


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.