N/A
N=162
Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.
Burn Injuries
Bottom Line
View on ClinicalTrials.gov: NCT01439074 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Time to Healing — 16; 17 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mepilex Ag (Device); Silver Sulphadiazine Ag cream (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Healing |
16; 17 | — |
| SECONDARY Percent of Burn Epithelised/Healed |
87.1; 85.2 | — |
| SECONDARY Number of Dressing Changes |
3.1; 14.0 | — |
| SECONDARY % of Study Burn Healed After One Week |
44.3; 27.0 | — |
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.
Eligibility 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;
- 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 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
Data sourced from ClinicalTrials.gov (NCT01439074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.