Conditions: Burn Injuries
Keywords: Burn injuries Mepilex Ag SSD Ag Partial thickness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 162
Healthy volunteers: no

Brief 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. 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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Mepilex Ag intervention 2: Silver Sulphadiazine Ag cream
Intervention descriptions: intervention 1: Dressing intervention 2: A cream used on burnt areas.

Protocol document: