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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Dressing
A cream used on burnt areas.
The 1st People's Hospital of Foshan
Guangdong, Guangdong, China
Guangzhou red Cross Hospital
Guangzhou, Guangdong, China
The First People's Hospital of ZhengZhou
Zhenzhou, Henan, China
The 3rd People's Hospital of Wuxi
Wuxi, Jiangsu, China
Time to Healing
Healing will be defined as number of days
Time frame: 4 weeks
Percent of Burn Epithelised/Healed
Healing will be defined as 95% or more epithelialisation
Time frame: 4 weeks
Number of Dressing Changes
Number of dressing changes including first assembly
Time frame: 4 weeks
% of Study Burn Healed After One Week
Time frame: 1 week
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