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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Ag | Device | Dressing |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Healing | Healing will be defined as number of days | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Burn Epithelised/Healed | Healing will be defined as 95% or more epithelialisation | 4 weeks |
| Number of Dressing Changes | Number of dressing changes including first assembly |
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Inclusion Criteria:
One study burn should be chosen which fulfil the following criteria;
All deep 2nd degree burn should be treated with the investigation product, Mepilex Ag/SSD (according to the randomization).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zia Zhaofan | Changahai Hospital of Shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st People's Hospital of Foshan | Guangdong | Guangdong | China | |||
| Guangzhou red Cross Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Ag | 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. Mepilex Ag: Dressing |
| FG001 | SSD Ag Cream | Silver Sulphadiazine Ag cream Silver sulphadiazine: Cream |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population/Safety population was chosen for the Overall Baseline Participants. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Ag | Mepilex Ag consists of a Safetac® soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex Ag: Dressing |
| BG001 | SSD Ag Cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Healing | Healing will be defined as number of days | ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint. | Posted | Mean | Standard Deviation | days | 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepilex Ag | 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. Mepilex Ag: Dressing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Xia, Zhaofan | Changhai Hospital of Shanghai | +86 2181873471 |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Silver Sulphadiazine Ag cream | Drug | A cream used on burnt areas. |
|
|
| 4 weeks |
| % of Study Burn Healed After One Week | 1 week |
| Guangzhou |
| Guangdong |
| 510220 |
| China |
| The First People's Hospital of ZhengZhou | Zhenzhou | Henan | China |
| The 3rd People's Hospital of Wuxi | Wuxi | Jiangsu | China |
| Beijing Jishuitan Hospital | Taiyuan | Shanxi | 30009 | China |
| Xijing Hospital | XiAn | Shanxi | China |
| The 2nd affiliated Hospital of KunMing Medical college | Kunming | Yunnan | China |
| Beijing Children's Hospital | Beijing | China |
| Changhai Hoospital of Shanghai | Shanghai | China |
| Withdrawal by Subject |
|
| Other |
|
Silver Sulphadiazine Ag white cream, 1% SSD Ag, 40g/tube Silver sulphadiazine: Cream |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Percent of Burn Epithelised/Healed | Healing will be defined as 95% or more epithelialisation | Posted | Mean | Standard Deviation | percentage of study burn healed | 4 weeks |
|
|
|
| Secondary | Number of Dressing Changes | Number of dressing changes including first assembly | ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint. | Posted | Mean | Standard Deviation | applications | 4 weeks |
|
|
|
| Secondary | % of Study Burn Healed After One Week | Posted | Mean | Standard Deviation | percentage of study burn healed | 1 week |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | SSD Ag Cream | Silver Sulphadiazine Ag cream Silver sulphadiazine: Cream | 0 | 82 | 0 | 82 |
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