Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.
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|ClinicalTrials.gov Identifier: NCT01439074|
Recruitment Status : Completed
First Posted : September 22, 2011
Results First Posted : October 1, 2014
Last Update Posted : December 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Burn Injuries||Device: Mepilex Ag Drug: Silver Sulphadiazine Ag cream||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Active Comparator: 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.
Device: Mepilex Ag
Other Name: Absorbent foam silver dressing
Active Comparator: Silver Sulphadiazine Ag cream
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.
Drug: Silver Sulphadiazine Ag cream
A cream used on burnt areas.
Other Name: SSD Ag cream, 1% SSD Ag, 40g/tube
- Time to Healing [ Time Frame: 4 weeks ]Healing will be defined as number of days
- Percent of Burn Epithelised/Healed [ Time Frame: 4 weeks ]Healing will be defined as 95% or more epithelialisation
- Number of Dressing Changes [ Time Frame: 4 weeks ]Number of dressing changes including first assembly
- % of Study Burn Healed After One Week [ Time Frame: 1 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439074
|The 1st People's Hospital of Foshan|
|Guangdong, Guangdong, China|
|Guangzhou red Cross Hospital|
|Guangzhou, Guangdong, China, 510220|
|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, China, 30009|
|XiAn, Shanxi, China|
|The 2nd affiliated Hospital of KunMing Medical college|
|Kunming, Yunnan, China|
|Beijing Children's Hospital|
|Changhai Hoospital of Shanghai|
|Principal Investigator:||Zia Zhaofan||Changahai Hospital of Shanghai|