Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: study protocol for a randomised controlled trial
| Autor: | Robert S. Ware, Steven M. McPhail, Jodie Wiseman, Megan Simons, Zephanie Tyack, Roy M. Kimble |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Burn injury
Time Factors Psychological intervention Medicine (miscellaneous) law.invention Silicone Gels Tertiary Care Centers 030207 dermatology & venereal diseases chemistry.chemical_compound Study Protocol 0302 clinical medicine Quality of life Randomized controlled trial Clinical Protocols law Medicine Pharmacology (medical) Child Children Burn scar Randomised controlled trial Age Factors Topical silicone gel Hospitals Pediatric Combined Modality Therapy Treatment Outcome Research Design Child Preschool Queensland Burns medicine.medical_specialty Adolescent Administration Cutaneous Clothing 03 medical and health sciences Cicatrix Silicone Pressure Humans Adverse effect Scar management Wound Healing business.industry 030208 emergency & critical care medicine Pressure garment therapy Clinical trial chemistry Multivariate Analysis Physical therapy business |
| Zdroj: | Trials |
| ISSN: | 1745-6215 1261-6001 |
| Popis: | Background Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar prevention and management techniques include silicone therapy, pressure garment therapy, or a combination of both. Currently, no definitive, high-quality evidence is available for the effectiveness of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population. Thus, this study aims to determine the effectiveness of these treatments in children. Methods A randomised controlled trial will be conducted at a large tertiary metropolitan children’s hospital in Australia. Participants will be randomised to one of three groups: Strataderm® topical silicone gel only, pressure garment therapy only, or combined Strataderm® topical silicone gel and pressure garment therapy. Participants will include 135 children (45 per group) up to 16 years of age who are referred for scar management for a new burn. Children up to 18 years of age will also be recruited following surgery for burn scar reconstruction. Primary outcomes are scar itch intensity and scar thickness. Secondary outcomes include scar characteristics (e.g. colour, pigmentation, pliability, pain), the patient’s, caregiver’s and therapist’s overall opinion of the scar, health service costs, adherence, health-related quality of life, treatment satisfaction and adverse effects. Measures will be completed on up to two sites per person at baseline and 1 week post scar management commencement, 3 months and 6 months post burn, or post burn scar reconstruction. Data will be analysed using descriptive statistics and univariate and multivariate regression analyses. Discussion Results of this study will determine the effectiveness of three noninvasive scar interventions in children at risk of, and with, scarring post burn or post reconstruction. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616001100482. Registered on 5 August 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1820-z) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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