Status:
COMPLETED
Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Burn Injuries
Eligibility:
All Genders
5-65 years
Phase:
NA
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-...
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 allocate...
Eligibility Criteria
Inclusion
- 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;
- isolated burn area (not head and/or face)
- 2nd degree deep partial
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01439074
Start Date
September 1 2011
End Date
September 1 2013
Last Update
December 18 2017
Active Locations (9)
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1
The 1st People's Hospital of Foshan
Guangdong, Guangdong, China
2
Guangzhou red Cross Hospital
Guangzhou, Guangdong, China, 510220
3
The First People's Hospital of ZhengZhou
Zhenzhou, Henan, China
4
The 3rd People's Hospital of Wuxi
Wuxi, Jiangsu, China