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

About this trial

Last updated 8 years ago

Study ID

PUMA 418

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

5 to 65 Years

All Sexes

Trial Timing

Ended 13 years ago

What is this trial about?

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.

What are the participation requirements?

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; 1. isolated burn area (not head and/or face) 2. 2nd degree deep partial 3. area is from 1 to 10% BSA 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