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

Molnlycke Health Care

Status: Completed

Conditions: Burn Injuries

Treatments: Device: Mepilex Ag; Drug: Silver Sulphadiazine Ag cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01439074

PUMA 418

Details and patient eligibility

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 5 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Mepilex Ag

Active Comparator group

Description:

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.

Treatment:

Device: Mepilex Ag

Silver Sulphadiazine Ag cream

Active Comparator group

Description:

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.

Treatment:

Drug: Silver Sulphadiazine Ag cream