Burns ScaldNCT04410497
Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds
A study testing Porcine xenograft (wound dressings) and Silver foam (wound dressings) in people with Burns Scald, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Prospective randomized trial where two dressings has been compared for partial thickness scald burns in children 6 months to 6 years. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Burns Scald
- What is being tested?
- Porcine xenograft (wound dressings) and Silver foam (wound dressings)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSweden
- Study dates
- 11 May 2015to 8 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children with other severe concomitant cutaneous trauma, skin disease, or children with a known hypersensitivity to silver.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Burn Centre at Linköping University Hospital,
Linköping, 58185
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns Scald
- Being tested
- Porcine xenograft (wound dressings), Silver foam (wound dressings)
- Keywords
- burns dressings healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porcine xenograft (wound dressings)Other
Also called EZderm from Mölnlycke Healthcare AB, Gothenburg, Sweden
commercial porcine xenograft, derived from acellular dermis from porcine.
Silver foam (wound dressings)Other
Also called Mepilex Ag from Mölnlycke Healthcare AB, Gothenburg, Sweden
commercial silver containing foam dressing
| Study group | Role | What they receive |
|---|---|---|
| Porcine xenograft | Experimental | Conformité Européenne/European Conformity (CE)-marked dressing product used in clinical practise (Standard of care). Receives: Other: Porcine xenograft (wound dressings) |
| Silver foam | Active comparator | Conformité Européenne/European Conformity (CE)- marked dressing product used in clinical practise Receives: Other: Silver foam (wound dressings) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Evaluated 2-3 times per week until complete wound closure, approximatley 15-20 days after injury (injury-complete healing)
Secondary outcomes (7)
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
Measured: 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)
Measured: 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
Measured: 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)
Measured: Evaluated after complete wound closure, approximatley 15-20 days after injury.
number of dressing changes required
documented in CRF and in medical records
Measured: 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
Measured: 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
Measured: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start11 May 2015
- Primary completion8 May 2018
- Study completion8 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns ScaldStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Folke Sjoberg, University Hospital, Linkoeping
- Investigators
- Johan Thorfinn, Ass.prof., Principal investigator, Linkoping Burn Centre, University hospital of Linkoping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410497
- Sponsor's protocol ID
- DPS-2014
- Status last verified
- May 2020
- First submitted
- 21 Nov 2018
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only if asked for
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04410497
- Acronym / sponsor ID
- DPS-2014
- Conditions
- Burns Scald
- Keywords
- burns dressings healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 11 May 2015 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.
| Arm | Type | Receives |
|---|---|---|
| Porcine xenograft | Experimental | Other: Porcine xenograft (wound dressings)Conformité Européenne/European Conformity (CE)-marked dressing product used in clinical practise (Standard of care). |
| Silver foam | Active comparator | Other: Silver foam (wound dressings)Conformité Européenne/European Conformity (CE)- marked dressing product used in clinical practise |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Children with other severe concomitant cutaneous trauma, skin disease, or children with a known hypersensitivity to silver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porcine xenograft (wound dressings)Also: EZderm from Mölnlycke Healthcare AB, Gothenburg, Swedencommercial porcine xenograft, derived from acellular dermis from porcine. | Other | Porcine xenograft |
| Silver foam (wound dressings)Also: Mepilex Ag from Mölnlycke Healthcare AB, Gothenburg, Swedencommercial silver containing foam dressing | Other | Silver foam |
Primary outcome
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
7 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.
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.
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.
Length of hospital stay
Time frame: Evaluated after complete wound closure, approximatley 15-20 days after injury.
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.
adverse events
Time frame: 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
Time frame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: No. only if asked for
Related trials for Burns Scald
Not yet recruiting
Nurse Led Aromatherapy
Burns and Scalds
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Thorfinn, Ass.prof. principal investigator
Linkoping Burn Centre, University hospital of Linkoping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Porcine xenograft (wound dressings) and Silver foam (wound dressings) in people with Burns Scald, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.