The Burn Centre at Linköping University Hospital,
Linköping, 58185, Sweden
Completed
NCT Number: NCT04410497
Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds
Prospective randomized trial where two dressings has been compared for partial thickness scald burns in children 6 months to 6 years.
Completed
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Conditions
Age range
6 month–6 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Porcine xenograft (wound dressings)
Othercommercial porcine xenograft, derived from acellular dermis from porcine.
Other names: EZderm from Mölnlycke Healthcare AB, Gothenburg, Sweden
Silver foam (wound dressings)
Othercommercial silver containing foam dressing
Other names: Mepilex Ag from Mölnlycke Healthcare AB, Gothenburg, Sweden
Primary outcomes
-
Time to complete wound closure
Time frame: 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 outcomes
-
Pain (at wound site)
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.
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
-
Need of surgery
Time frame: 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
Time frame: 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
Time frame: Evaluated after complete wound closure, approximatley 15-20 days after injury.
number of days when the child received in hospital care (including readmissions)
-
number of dressing changes required
Time frame: 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
-
adverse events
Time frame: 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
Time frame: 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
Sponsors and collaborators
Lead sponsor
University Hospital, Linkoeping
Other
Registry information
Official study title
Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds: A Prospective Randomized Controlled Trial
Important dates
- Study start
- 2015
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jun 1, 2020
- Registry last updated
- Jun 1, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.