None listed
Conditions
Brief summary
Background: Although Negative Pressure Wound Therapy (NPWT) has become widely used in the management of several wound types, its efficacy as a primary therapy for acute burns has never been adequately investigated, with research in children particularly lacking. There is limited evidence, however, that NPWT might benefit paediatric burns patients, 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 routine treatment alone. Methods: A total of 96 paediatric burns patients will be recruited for this trial. To be eligible, candidates must be under 17 years of age and present with a thermal burn covering <5% of their total body surface area to the participating children’s hospital within 7 days of their injury. 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™, secured with Hypafix™. The intervention arm will be treated with silver-impregnated dressings in addition to NPWT via the RENASYS TOUCH™ vacuum pump. Participants will undergo dressing changes every 3-5 days until the point of healing. The primary endpoint will be time to re-epithelialisation. Secondary outcomes include pain, pruritus, wound progression, cost effectiveness, ease of management, treatment satisfaction, and adverse events. A linear mixed model will be performed to determine the evolution across time and between groups in primary and secondary outcomes, with patients as random effect. Wound fluid collected during NPWT will also be analysed to generate a proteomic profile of the burn microenvironment. Discussion: The study will be the first randomised controlled trial to explore the effects of NPWT on paediatric burns, with the aim of determining whether the therapy warrants implementation as an adjunct to standard burns management.
Interventions
Patients allocated to the intervention group will have their wounds first dressed in the Pegg Leditschke Paediatric Burns Centre (PLPBC) or the Lady Cilento Children's Hospital Emergency Department (ED) with a combination of standard dressings (Acticoat™ and Mepitel™). Additionally, an experienced burns clinician will provide these patients Negative Pressure Wound Therapy (NWPT) using a RENASYS TOUCH™ (Hull, UK, Smith & Nephew) suction device set at a continuous pressure of -80 mmHg. These thera
Patients allocated to the intervention group will have their wounds first dressed in the Pegg Leditschke Paediatric Burns Centre (PLPBC) or the Lady Cilento Children's Hospital Emergency Department (ED) with a combination of standard dressings (Acticoat™ and Mepitel™). Additionally, an experienced burns clinician will provide these patients Negative Pressure Wound Therapy (NWPT) using a RENASYS TOUCH™ (Hull, UK, Smith & Nephew) suction device set at a continuous pressure of -80 mmHg. These therapies will be administered at the time of randomisation and replaced every 3-5 days until the burn is 95% re-epithelialised, or until grafting is required.
Sponsors
The University of Queensland
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
Children aged 0-16 years presenting with a thermal burn to the Emergency Department or Pegg Leditschke Children’s Burns Centre at the Lady Cilento Children’s Hospital, Brisbane, within 7 days post-injury.
Exclusion criteria
• Burns covering 5% or more of the total body surface area (TBSA) • Trivial burns (at the discretion of the burns surgeon) • Facial burns
Outcome results
None listed