Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds

University Hospital, Linkoeping

Status: Completed

Conditions: Burns Scald

Treatments: Other: Porcine xenograft (wound dressings); Other: Silver foam (wound dressings)

Study type: Interventional

Funder types: Other

Identifiers

NCT04410497

DPS-2014

Details and patient eligibility

About

Prospective randomized trial where two dressings has been compared for partial thickness scald burns in children 6 months to 6 years.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Porcine xenograft

Experimental group

Description:

Conformité Européenne/European Conformity (CE)-marked dressing product used in clinical practise (Standard of care).

Treatment:

Other: Porcine xenograft (wound dressings)

Silver foam

Active Comparator group

Description:

Conformité Européenne/European Conformity (CE)- marked dressing product used in clinical practise

Treatment:

Other: Silver foam (wound dressings)