Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds

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

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

Study Overview

• Status: Completed
• Conditions: Burns Scald
• Intervention / Treatment: Other: Porcine xenograft (wound dressings); Other: Silver foam (wound dressings)

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 58185
    • The Burn Centre at Linköping University Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Investigators: Principal Investigator: Johan Thorfinn, Ass.prof., Linkoping Burn Centre, University hospital of Linkoping, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2015
• Primary Completion (Actual): May 8, 2018
• Study Completion (Actual): May 8, 2018

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: burns dressings healing
• Other Study ID Numbers: DPS-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: only if asked for

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No