Prospective randomized trial where two dressings has been compared for partial thickness scald burns in children 6 months to 6 years.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
commercial porcine xenograft, derived from acellular dermis from porcine.
commercial silver containing foam dressing
The Burn Centre at Linköping University Hospital,
Linköping, Sweden
Time to complete wound closure
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
Time frame: Evaluated 2-3 times per week until complete wound closure, approximatley 15-20 days after injury (injury-complete healing)
Pain (at wound site)
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
Time frame: Evaluated before,during and after dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
Need of surgery
Evaluated as yes or no (surgery perfomered according to the medical record)
Time frame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
Burn wound infection
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
Time frame: Evaluated at each dressing change; 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
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Length of hospital stay
number of days when the child received in hospital care (including readmissions)
Time frame: Evaluated after complete wound closure, approximatley 15-20 days after injury.
number of dressing changes required
documented in CRF and in medical records
Time frame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
adverse events
any local reaction seen in or around wound during the time when study dressings were used
Time frame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
Minutes needed for application and removal of dressing
documented in CRF and in medical records
Time frame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.