Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds: A Prospective Randomized Controlled Trial

Conditions
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Burns Scald

Intervention / Treatment
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* Other: Porcine xenograft (wound dressings)
* Other: Silver foam (wound dressings)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Porcine xenograft<br>Conformité Européenne/European Conformity (CE)-marked dressing product used in clinical practise (Standard of care). | Other: Porcine xenograft (wound dressings)<br>* commercial porcine xenograft, derived from acellular dermis from porcine.<br>* Other names: EZderm from Mölnlycke Healthcare AB, Gothenburg, Sweden;|
| Active Comparator: Silver foam<br>Conformité Européenne/European Conformity (CE)- marked dressing product used in clinical practise | Other: Silver foam (wound dressings)<br>* commercial silver containing foam dressing<br>* Other names: Mepilex Ag from Mölnlycke Healthcare AB, Gothenburg, Sweden;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burns dressings healing