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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molnlycke Health Care AB
• Treatments: Silver Sulfadiazine; Sulfadiazine

Criteria

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