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Trial registered on ANZCTR


Registration number
ACTRN12610000956000
Ethics application status
Approved
Date submitted
2/11/2010
Date registered
8/11/2010
Date last updated
8/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective Randomised Controlled Trial Comparing Versajet Hydrosurgery Debridement and Conventional Debridement in Paediatric Burns Patients
Scientific title
Prospective randomised controlled trial comparing Versajet hydrosurgery debridement and conventional debridement in the precision of debridement and long-term scar outcome in paediatric burns patients
Secondary ID [1] 253008 0
10/CHW/38 Human Research Ethics Committee
Universal Trial Number (UTN)
U1111-1117-6625
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric burns 258552 0
Condition category
Condition code
Surgery 258697 258697 0 0
Surgical techniques
Injuries and Accidents 258757 258757 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Versajet Hydrosurgery System is a tool that provides a high-pressure water jet capable of cutting tissue. It uses a high velocity sterile saline jet to cut/ debride the tissues and then draws tissue and fluid into a chamber via the Venturi effect created by the saline jet. This focused water jet passes parallel to the wound and is captured by an evacuator port which is located 8mm or 14mm from the nozzle. This jet of pressurised saline functions like a knife and the handpiece allows debridement and aspiration of debris to occur simultaneously. The Versajet system is currently utilised across many burns centres and at the Children’s Hospital at Westmead by the majority of burns surgeons and is considered a standard practice in selected cases. However, current literature regarding its clinical effectiveness (compared to the conventional tangential method of debridement using sharp excision) is scarce. The duration of debridement is dependent on the size (and depth) of the burn - approximately 10mins in burns of less than 5% TBSA. Some surgeons report that Versajet debridement is faster than conventional tangential excision in areas that are difficult to debride such as the hands, feet or perineum.
Intervention code [1] 257528 0
Treatment: Surgery
Comparator / control treatment
Conventional surgical debridement of a burn wound relies on tangential excision of non viable tissue using either sharp dissection or dermabrasion. This form of debridement relies upon progressive tangential excision of the burn wound until a level of viable tissue is reached. This depth is determined by the presence of punctate bleeding. Duration of debridement again depends on the surface area to be debrided - it may vary from 15-20 mins in burns of less than 5% TBSA to 20-25 mins in burns of greater than 5% TBSA.
Control group
Active

Outcomes
Primary outcome [1] 259558 0
scar outcome
Timepoint [1] 259558 0
Vancouver Scar Scale score at 3 months
Primary outcome [2] 259559 0
percentage graft take using a wound grid (eg. Visitrak)
Timepoint [2] 259559 0
at Day 10
Primary outcome [3] 259560 0
microbiology swab result
Timepoint [3] 259560 0
immediately after debridement
Secondary outcome [1] 266176 0
duration of debridement
Timepoint [1] 266176 0
at time of surgery
Secondary outcome [2] 266177 0
histological precision of debridement
Timepoint [2] 266177 0
skin punch biopsy will be obtained pre and post debridement at the time of surgery

Eligibility
Key inclusion criteria
All patients with a burn that requires debridement and undergoes acute skin grafting at The Children’s Hospital at Westmead (CHW) will be eligible for the study. Prior to entry into the study, written consent will be obtained by all patients or their guardians.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing debridement without grafting, or with delayed grafting, will be excluded from the study. Patients with facial burns alone will be excluded from the study. Full thickness burns will be excluded from the 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)
After consent has been obtained, participants will be stratified into two categories (less than 10% total burns surface area and greater than 10% TBSA) and randomised into two groups. Group 1 is a control group that will undergo the gold standard form of debridement (tangential blade excision) prior to grafting. Group two will undergo Versajet hydrosurgery debridement. Computer generated envelopes will be chosen in theatre just prior to debridement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
stratified allocation - subjects will be stratified into two categories (less than 10% total burns surface area and greater than 10% TBSA) and randomised into the two interventional groups.
Masking / blinding
Blinded (masking 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
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257980 0
Hospital
Name [1] 257980 0
Burns Unit
Country [1] 257980 0
Australia
Primary sponsor type
Individual
Name
Dr John Harvey
Address
The Children's Hospital at Westmead
Hawkesbury Road, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 257177 0
Individual
Name [1] 257177 0
A/Prof Andrew Holland
Address [1] 257177 0
The Children's Hospital at Westmead
Hawkesbury Road, Westmead NSW 2145
Country [1] 257177 0
Australia
Secondary sponsor category [2] 257178 0
Individual
Name [2] 257178 0
Dr Queenie Chan
Address [2] 257178 0
The Children's Hospital at Westmead
Hawkesbury Rd, Westmead NSW 2145
Country [2] 257178 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259981 0
The Children's Hospital Westmead HREC
Ethics committee address [1] 259981 0
Research and Development Centre
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145
Ethics committee country [1] 259981 0
Australia
Date submitted for ethics approval [1] 259981 0
25/06/2010
Approval date [1] 259981 0
29/09/2010
Ethics approval number [1] 259981 0
10/CHW/38

Summary
Brief summary
The purpose of the trial is to conduct a prospective randomised controlled trial of Versajet hydrosurgery debridement (removal of necrotic/ non-viable tissue) of burns versus conventional tangential excisional debridement in paediatric patients. To date no trial has compared excisional debridement with Versajet hydrosurgery in paediatric burns patients. Our hypotheses is that
1.Versajet debridement leads to increased dermal preservation and accuracy of debridement
2.Versajet debridement is faster than conventional tangential excision in areas that are difficult to debride such as the hands, feet or perineum.
3.Graft healing time is equivalent following Versajet or classical blade debridement
4.Versajet debridement leads to improved outcomes post skin grafting such as hypertrophic scarring and contracture
5.Bacterial load is lower in the Versajet group following debridement
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31860 0
Address 31860 0
Country 31860 0
Phone 31860 0
Fax 31860 0
Email 31860 0
Contact person for public queries
Name 15107 0
Dr Queenie Chan
Address 15107 0
Burns Unit
The Children's Hospital at Westmead
Hawkesbury Road
Westmead NSW 2145
Country 15107 0
Australia
Phone 15107 0
+61 2 9845 0000
Fax 15107 0
Email 15107 0
[email protected]
Contact person for scientific queries
Name 6035 0
Dr John Harvey
Address 6035 0
Department of Surgery
The Children's Hospital at Westmead
Hawkesbury Road
Westmead NSW 2145
Country 6035 0
Australia
Phone 6035 0
+61 2 9845 0000
Fax 6035 0
Email 6035 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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