Burns Scald
Conditions
Keywords
burns dressings healing
Brief summary
Prospective randomized trial where two dressings has been compared for partial thickness scald burns in children 6 months to 6 years.
Detailed description
Aim: The aim of this study was to compare two different treatment regimes for children with partial-thickness scald burns. Burns were treated with either a porcine xenograft (EZderm®, Mölnlycke Health Care, Gothenburg, Sweden) or a silver foam dressing (Mepilex® Ag, Mölnlycke Health Care, Gothenburg, Sweden). Methods: A prospective randomized clinical trial including 58 children admitted between May 2015 and May 2018 for partial-thickness scalds to The Burn Centre in Linkoping, Sweden. Primary outcome was time to wound closure. Secondary outcomes were pain, need of surgery, wound infection, length of hospital stay, required dressings changes, and labour time.
Interventions
OTHERPorcine xenograft (wound dressings)
commercial porcine xenograft, derived from acellular dermis from porcine.
OTHERSilver foam (wound dressings)
commercial silver containing foam dressing
Sponsors
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
* Partial-thickness scald burns admitted within 72 hours of injury and with burns suitable for porcine xenograft according to the burn surgeon on duty were eligible and enrolled after (guardians) consenting to participate.
Exclusion criteria
* Children with other severe concomitant cutaneous trauma, skin disease, or children with a known hypersensitivity to silver.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete wound closure | Evaluated 2-3 times per week until complete wound closure, approximatley 15-20 days after injury (injury-complete healing) | Calculated from the date of injury to the date when the wound bed was assessed as completely reepithelialized with no necessity for further wound dressings other than a protective dressing against shearing, according to both the attending physician and nurse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need of surgery | Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury. | Evaluated as yes or no (surgery perfomered according to the medical record) |
| Burn wound infection | Evaluated at each dressing change; 2-3 times per week until complete wound closure, approximatley 15-20 days after injury. | Children were diagnosed with burn wound infection by the burn surgeon and a consultant physician specialized in infectious diseases if fulfilling at least two of the following criteria based on American Burn Association definition of burn wound infection * Clinical signs such as localised pain and swelling, spreading erythema (redness), and heat at the affected site. * Surface wound swab culture presenting a minimum of 106 colony-forming units (CFU)/L (equivalent to the ABA definition of 105 CFU/g) \[29\]. * Systemic signs of infection indicated as a rise of C-reactive protein (CRP) level (reference range \< 10 mg/L for capillary sampling) together with increased body temperature exceeding 38 °C- 48 hours after injury where other sources of infection are excluded |
| Length of hospital stay | Evaluated after complete wound closure, approximatley 15-20 days after injury. | number of days when the child received in hospital care (including readmissions) |
| Pain (at wound site) | Evaluated before,during and after dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury. | Pain is to evaluated by staff before, during and after wound dressing Changes using the Face, Legs, Activity, Cry, Consolability, behavioural pain scale (FLACC) is a five-category behavioral instrument where each category is scored on a scale of 0-2, resulting in a result between 0-10 |
| adverse events | Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury. | any local reaction seen in or around wound during the time when study dressings were used |
| Minutes needed for application and removal of dressing | Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury. | documented in CRF and in medical records |
| number of dressing changes required | Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury. | documented in CRF and in medical records |
Countries
Sweden
Outcome results
None listed