Abstract
BackgroundAlthough negative pressure wound therapy (NPWT) is widely used in the management of several wound types, its efficacy as a primary therapy for acute burns has not yet been adequately investigated, with research in the paediatric population particularly lacking. There is limited evidence, however, that NPWT might benefit children with burns, amongst whom scar formation, wound progression and pain continue to present major management challenges. The purpose of this trial is to determine whether NPWT in conjunction with standard therapy accelerates healing, reduces wound progression and decreases pain more effectively than standard treatment alone.Methods/designA total of 104 children will be recruited for this trial. To be eligible, candidates must be under 17 years of age and present to the participating children’s hospital within 7 days of their injury with a thermal burn covering <5% of their total body surface area. Facial and trivial burns will be excluded. Following a randomised controlled parallel design, participants will be allocated to either an active control or intervention group. The former will receive standard therapy consisting of Acticoat™ and Mepitel™. The intervention arm will be treated with silver-impregnated dressings in addition to NPWT via the RENASYS TOUCH™ vacuum pump. Participants’ dressings will be changed every 3 to 5 days until their wounds are fully re-epithelialised. Time to re-epithelialisation will be studied as the primary outcome. Secondary outcomes will include pain, pruritus, wound progression, health-care-resource use (and costs), ease of management, treatment satisfaction and adverse events. Wound fluid collected during NPWT will also be analysed to generate a proteomic profile of the burn microenvironment.DiscussionThe study will be the first randomised controlled trial to explore the clinical effects of NPWT on paediatric burns, with the aim of determining whether the therapy warrants implementation as an adjunct to standard burns management.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618000256279. Registered on 16 February 2018.
Highlights
Negative pressure wound therapy (NPWT) is widely used in the management of several wound types, its efficacy as a primary therapy for acute burns has not yet been adequately investigated, with research in the paediatric population lacking
The study will be the first randomised controlled trial to explore the clinical effects of negative pressure wound therapy (NPWT) on paediatric burns, with the aim of determining whether the therapy warrants implementation as an adjunct to standard burns management
At one of Australia’s largest tertiary paediatric burns centres, over 62% of patients present with wounds covering less than 1% of their total body surface area (TBSA), and more than 90% of all burns are thermal in origin [9]
Summary
Over the past two decades, NPWT has been extensively applied and studied in the management of a wide variety of wounds, even prompting some authors to remark that it has “overwhelmed the wound-healing world” [129]. For the latter, the burns seen over the course of even a single day tend to vary significantly in terms of first aid, prior treatment and time to presentation. By measuring the impact of NPWT on re-epithelialisation, burn wound progression and pain, the study aims to address the gaps in the NPWT literature and determine whether the therapy warrants implementation as an adjunct to standard therapy Trial status This manuscript represents the 15th version of the trial protocol, completed on 15 January 2019.
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