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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Porcine xenograft | Experimental | Conformité Européenne/European Conformity (CE)-marked dressing product used in clinical practise (Standard of care). |
|
| Silver foam | Active Comparator | Conformité Européenne/European Conformity (CE)- marked dressing product used in clinical practise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porcine xenograft (wound dressings) | Other | commercial porcine xenograft, derived from acellular dermis from porcine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Evaluated 2-3 times per week until complete wound closure, approximatley 15-20 days after injury (injury-complete healing) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Evaluated before,during and after dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Thorfinn, Ass.prof. | Linkoping Burn Centre, University hospital of Linkoping, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Burn Centre at Linköping University Hospital, | Linköping | 58185 | Sweden |
only if asked for
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Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.
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| Silver foam (wound dressings) | Other | commercial silver containing foam dressing |
|
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| Need of surgery | Evaluated as yes or no (surgery perfomered according to the medical record) | 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
| Evaluated at each dressing change; 2-3 times per week until complete wound closure, approximatley 15-20 days after injury. |
| Length of hospital stay | number of days when the child received in hospital care (including readmissions) | Evaluated after complete wound closure, approximatley 15-20 days after injury. |
| number of dressing changes required | documented in CRF and in medical records | 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 | 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 | Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury. |