None listed
Conditions
Brief summary
Burn wound progression can be variable after the initial injury has occurred. Tissue oedema as a result of the injury can compromise microcirculation resulting in this progression. Pressure applied to this area through NPWT is known to squeeze oedema fluid out of the interstitial space. It is plausible that applying NPWT within this initial timeframe may halt or limit burn wound progression. The use of Negative Pressure Wound therapy (NPWT) in the treatment of burns has increased over the past decade. It is common practice at the Pegg Leditschke Children’s Burns Centre, Queensland Children’s Hospital to apply NPWT post-split thickness graft to improve take of the graft and more recently it’s efficacy in acute burns has been tested using the Renasys Go. More recently the Renasys Go has been trialled in the unit for burns less than 5% TBSA within 1 week of injury. This study found improved clinical outcomes, especially when applied within 48 hours. However, parents reported a burden due to the size of the Renasys Go and need for recharging accessories. There is lack of information regarding the use of the smaller, battery operated NPWT device, PICO, as a primary treatment for acute burns. Applying NPWT could greatly improve the final outcome of a burn wound. This could have multiple implications as improved time to re-epithelialisation can impact on overall cost of treatment, requirements for scar management as well as possible reconstructive requirement in the future. This study will address the paucity of knowledge of “ultra portable” negative pressure devices for use in acute burn wound care. This will build on knowledge recently acquired in a randomised controlled with a larger device (Smith and Nephew – Renasys Go). This study aims to establish the feasibility and safety for the use of the ultra-portable PICO negative pressure device in children with burn injuries.
Interventions
This is a three arm study, with one arm being the control group and then two being interventions.
Intervention one – standard dressing (mepitel, acticoat) with the PICO dressing
Intervention two – mepitel, acticoat flex with the PICO dressing
Which intervention a patient is allocated to will depend on which group they are randomised to via redcap.
The patient would usually receive mepitel and acticoat with hypafix on a standard burn. In intervention one, mepitel and acticoat will be applie
This is a three arm study, with one arm being the control group and then two being interventions. Intervention one – standard dressing (mepitel, acticoat) with the PICO dressing Intervention two – mepitel, acticoat flex with the PICO dressing Which intervention a patient is allocated to will depend on which group they are randomised to via redcap. The patient would usually receive mepitel and acticoat with hypafix on a standard burn. In intervention one, mepitel and acticoat will be applied but then a PICO dressing will be applied over the top. This device applies NPWT at -80mmHg. Intervention two is very similar to intervention one. However, we will use acticoat instead of acticoat flex. The reason for inclusion of this branch is it may sit better underneath the PICO dressing than the pure acticoat. The PICO will be turned on once applied and then left on delivering pressure at -80mmHg continuously for 3-5 days. The PICO dressing will be removed at the first dressing change, and then the dressings will return to standard dressings. The PICO dressings will be applied by experienced burns clinicians – including burns surgeons and nurses. Each of these people will have had a minimum of three years clinical experience. These dressings will be applied face to face. The intervention location will be the Queensland Children’s Hospital. Adherence will be assessed by review at outpatient clinic. If the patient does not attend clinic, we will call the patient/family multiple times to ensure they are not lost to follow up.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Age less than or equal to 16 years of age 2. Must present within 48hours of sustaining a burn injury 3. All burn depths 4. All mechanisms (excluding electrocution) 5. Burn wound must be contained within the size of the available PICO dressings 6. Flat surfaces
Exclusion criteria
1. Older than 16yrs of age 2. Burns located on face, fingers, toes, elbows, knees, or other non flat surfaces 3. The area of burn can not be contained within the standard PICO dressings sizes 4. Clinician treatment priority contradicts randomisation
Outcome results
None listed