Clinical trial NCT04410497: Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds
Official title: Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns Scald
Keywords: burns dressings healing
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to complete wound closure
timeFrame: Evaluated 2-3 times per week until complete wound closure, approximatley 15-20 days after injury (injury-complete healing)
Secondary outcomes:
measure: Pain (at wound site)
timeFrame: Evaluated before,during and after dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
measure: Need of surgery
timeFrame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
measure: Burn wound infection
timeFrame: Evaluated at each dressing change; 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
measure: Length of hospital stay
timeFrame: Evaluated after complete wound closure, approximatley 15-20 days after injury.
measure: number of dressing changes required
timeFrame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
measure: adverse events
timeFrame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
measure: Minutes needed for application and removal of dressing
timeFrame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: The Burn Centre at Linköping University Hospital,
Study officials:
affiliation: Linkoping Burn Centre, University hospital of Linkoping, Sweden
name: Johan Thorfinn, Ass.prof.
role: PRINCIPAL_INVESTIGATOR
References: