Burn InjuriesNCT01439074
Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.
A study testing Mepilex Ag and Silver Sulphadiazine Ag cream in people with Burn Injuries, run by Molnlycke Health Care AB at 9 sites in China.
Trial summary
The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in China will be evaluated. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Burn Injuries
- What is being tested?
- Mepilex Ag and Silver Sulphadiazine Ag cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 9 sitesChina
- Study dates
- Sep 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with a deep partial-thickness burn injury covering 2.5%-25% TBSA (3rd degree areas not to exceed 10% TBSA)
- Burn of thermal origin
- Both gender with an age ≥5 years and ≤65 years at ICF
- Understood and signed informed consent
- Subjects who are younger than the legal consenting age must have a legally authorized representative
- One study burn should be chosen which fulfil the following criteria;
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- isolated burn area (not head and/or face)
- 2nd degree deep partial
- area is from 1 to 10% BSA
- All deep 2nd degree burn should be treated with the investigation product, Mepilex Ag/SSD (according to the randomization).
Who cannot join
- Burns "occurred" equal to or older than 36 hours
- Burns of chemical and electrical origin
- Clinically infected burn (as judged by the investigator)
- Subjects with lung injury or subjects being on a ventilator
- Treatment of the burn with an active agent before study entry. SSD is allowed up to 24 hours prior to randomization
- Subjects with dermatologic skin disorders or necrotizing processes
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- Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment
- Subjects with insulin dependent diabetes mellitus
- Subjects treated with systemic glucocorticosteroids, except Subjects taking occasional doses or doses less than 10mg prednisolon (day or equivalent
- Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
- Known allergy/hypersensitivity to any of the components (SSD , Ag glycerin, monostearate, glycerol, cetearyl alcohol, leveling agent O, albolene, light liquid paraffin, ethylparaben/ silicone, polyurethane foam pad containing a silver compound, activated carbon)of the investigation products
- Subjects with physical and/or mental conditions that are not expected to comply with the investigation
- Participation in other clinical investigation(s) within 1 month prior to start of the investigation
- Pregnancy (pregnancy test needed if they do not use contraceptive)
- Previously randomized to this investigation (PUMA 418
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Children's Hospital
Beijing
The 1st People's Hospital of Foshan
Guangdong, Guangdong
Guangzhou red Cross Hospital
Guangzhou, Guangdong, 510220
The 2nd affiliated Hospital of KunMing Medical college
Kunming, Yunnan
Changhai Hoospital of Shanghai
Shanghai
Beijing Jishuitan Hospital
Taiyuan, Shanxi, 30009
The 3rd People's Hospital of Wuxi
Wuxi, Jiangsu
Xijing Hospital
XiAn, Shanxi
The First People's Hospital of ZhengZhou
Zhenzhou, Henan
About this study
Official title: An Open, Randomized, Comparative, Multi-centre Investigation Evaluating the Efficacy and Tolerance of Mepilex Ag Versus Silver Sulfadiazine in the Treatment of Deep Partial Thickness Burn Injuries.
The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.
Read the detailed description
Subjects enrolled in this investigation were in-patients at eleven centers in China. To be included, subjects had to have deep partial-thickness burn injuries. The subjects were consecutively allocated to a subject code providing they fulfilled all inclusion criteria and none of the exclusion criteria and had signed a written informed consent form. Two evaluators independent of each other made the judgment regarding depth of the burn before enrolling a subject. The subjects were randomized to either receive Mepilex Ag or SSD.
Treatment period were up to four weeks with either SSD or Mepilex Ag. Changes of the investigation products were performed according to a standardized schedule, unless the wound healed before.
- Conditions
- Burn Injuries
- Being tested
- Mepilex Ag, Silver Sulphadiazine Ag cream
- Keywords
- Burn injuries, Mepilex Ag, SSD Ag, Partial thickness
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex AgDevice
Also called Absorbent foam silver dressing
Dressing
Silver Sulphadiazine Ag creamDrug
Also called SSD Ag cream, 1% SSD Ag, 40g/tube
A cream used on burnt areas.
| Study group | Role | What they receive |
|---|---|---|
| Mepilex Ag | Active comparator | Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Receives: Device: Mepilex Ag |
| Silver Sulphadiazine Ag cream | Active comparator | SSD Ag cream is white cream, 1% SSD Ag, 40g/tube This cream is indicated for prevent and treat secondary wound infection of small area, mild burn/scald. Receives: Drug: Silver Sulphadiazine Ag cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Healing
Healing will be defined as number of days
Measured: 4 weeks
Secondary outcomes (3)
Percent of Burn Epithelised/Healed
Healing will be defined as 95% or more epithelialisation
Measured: 4 weeks
Number of Dressing Changes
Number of dressing changes including first assembly
Measured: 4 weeks
% of Study Burn Healed After One Week
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Burn InjuriesStudies 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
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zia Zhaofan, Principal investigator, Changahai Hospital of Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439074
- Sponsor's protocol ID
- PUMA 418
- Status last verified
- Dec 2013
- First submitted
- 21 Sep 2011
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Comparative, Multi-centre Investigation Evaluating the Efficacy and Tolerance of Mepilex Ag Versus Silver Sulfadiazine in the Treatment of Deep Partial Thickness Burn Injuries.
- ClinicalTrials.gov ID
- NCT01439074
- Acronym / sponsor ID
- PUMA 418
- Conditions
- Burn Injuries
- Keywords
- Burn injuries, Mepilex Ag, SSD Ag, Partial thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Posted 1 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.
Detailed description
Subjects enrolled in this investigation were in-patients at eleven centers in China. To be included, subjects had to have deep partial-thickness burn injuries. The subjects were consecutively allocated to a subject code providing they fulfilled all inclusion criteria and none of the exclusion criteria and had signed a written informed consent form. Two evaluators independent of each other made the judgment regarding depth of the burn before enrolling a subject. The subjects were randomized to either receive Mepilex Ag or SSD.
Treatment period were up to four weeks with either SSD or Mepilex Ag. Changes of the investigation products were performed according to a standardized schedule, unless the wound healed before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepilex Ag | Active comparator | Device: Mepilex AgMepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. |
| Silver Sulphadiazine Ag cream | Active comparator | Drug: Silver Sulphadiazine Ag creamSSD Ag cream is white cream, 1% SSD Ag, 40g/tube This cream is indicated for prevent and treat secondary wound infection of small area, mild burn/scald. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with a deep partial-thickness burn injury covering 2.5%-25% TBSA (3rd degree areas not to exceed 10% TBSA)
- Burn of thermal origin
- Both gender with an age ≥5 years and ≤65 years at ICF
- Understood and signed informed consent
- Subjects who are younger than the legal consenting age must have a legally authorized representative
Key exclusion criteria (15 listed)
- Burns "occurred" equal to or older than 36 hours
- Burns of chemical and electrical origin
- Clinically infected burn (as judged by the investigator)
- Subjects with lung injury or subjects being on a ventilator
- Treatment of the burn with an active agent before study entry. SSD is allowed up to 24 hours prior to randomization
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 |
|---|---|---|
| Mepilex AgAlso: Absorbent foam silver dressingDressing | Device | Mepilex Ag |
| Silver Sulphadiazine Ag creamAlso: SSD Ag cream, 1% SSD Ag, 40g/tubeA cream used on burnt areas. | Drug | Silver Sulphadiazine Ag cream |
Primary outcome
Time to Healing
Time frame: 4 weeks
Healing will be defined as number of days
3 secondary outcomes
Percent of Burn Epithelised/Healed
Time frame: 4 weeks
Number of Dressing Changes
Time frame: 4 weeks
% of Study Burn Healed After One Week
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Zia Zhaofan principal investigator
Changahai Hospital of Shanghai
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Ag and Silver Sulphadiazine Ag cream in people with Burn Injuries, run by Molnlycke Health Care AB at 9 sites in China.
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 10 inclusion and 15 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 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Healing (time frame: 4 weeks). 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 18 Dec 2017.