Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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;

All deep 2nd degree burn should be treated with the investigation product, Mepilex Ag/SSD (according to the randomization).

Exclusion Criteria

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
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

Arm && Interventions

Group	Intervention	Description
Silver Sulphadiazine Ag cream	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.
Mepilex Ag	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.

Primary Outcome Measures

Name	Time	Method
Time to Healing	4 weeks	Healing will be defined as number of days

Secondary Outcome Measures

Name	Time	Method
Percent of Burn Epithelised/Healed	4 weeks	Healing will be defined as 95% or more epithelialisation
Number of Dressing Changes	4 weeks	Number of dressing changes including first assembly
% of Study Burn Healed After One Week	1 week

Locations (9): Beijing Children's Hospital
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Beijing, China
The 1st People's Hospital of Foshan
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Guangdong, Guangdong, China
Beijing Jishuitan Hospital
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Taiyuan, Shanxi, China
Guangzhou red Cross Hospital
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Guangzhou, Guangdong, China
The 2nd affiliated Hospital of KunMing Medical college
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Kunming, Yunnan, China
The First People's Hospital of ZhengZhou
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Zhenzhou, Henan, China
The 3rd People's Hospital of Wuxi
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Wuxi, Jiangsu, China
Changhai Hoospital of Shanghai
🇨🇳
Shanghai, China
Xijing Hospital
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XiAn, Shanxi, China