Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds

Burns Scald Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410497
• Other study ID #: DPS-2014
• Status: Completed
• Phase: N/A
• Start date: May 11, 2015
• Est. completion date: May 8, 2018

Study information

• Verified date: May 2020
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 8, 2018
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns Scald

Intervention

Other:
• Porcine xenograft (wound dressings)
commercial porcine xenograft, derived from acellular dermis from porcine.
• Silver foam (wound dressings)
commercial silver containing foam dressing

Locations

Country	Name	City	State
Sweden	The Burn Centre at Linköping University Hospital,	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.