Burn Injuries
Conditions
Keywords
Burn injuries, Mepilex Ag, SSD Ag, Partial thickness
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-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.
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 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.
Interventions
DEVICEMepilex Ag
Dressing
DRUGSilver Sulphadiazine Ag cream
A cream used on burnt areas.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Healing | 4 weeks | Healing will be defined as number of days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Burn Epithelised/Healed | 4 weeks | Healing will be defined as 95% or more epithelialisation |
| Number of Dressing Changes | 4 weeks | Number of dressing changes including first assembly |
| % of Study Burn Healed After One Week | 1 week | — |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mepilex Ag Mepilex Ag consists of a Safetac® soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.
Mepilex Ag: Dressing | 71 |
| SSD Ag Cream Silver Sulphadiazine Ag white cream, 1% SSD Ag, 40g/tube
Silver sulphadiazine: Cream | 82 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Other | 4 | 4 |
| Overall Study | Subject shedding | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | SSD Ag Cream | Mepilex Ag | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 3 Participants | 9 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants | 68 Participants | 144 Participants |
| Age, Continuous | 35.4 years STANDARD_DEVIATION 13.2 | 37.0 years STANDARD_DEVIATION 12.3 | 36.2 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment China | 82 participants | 71 participants | 153 participants |
| Sex: Female, Male Female | 25 Participants | 16 Participants | 41 Participants |
| Sex: Female, Male Male | 57 Participants | 55 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 71 | 0 / 82 |
| serious Total, serious adverse events | 0 / 71 | 0 / 82 |
Outcome results
Primary
Time to Healing
Healing will be defined as number of days
Time frame: 4 weeks
Population: ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mepilex Ag | Time to Healing | 16 days | Standard Deviation 7.27 |
| SSD Ag Cream | Time to Healing | 17 days | Standard Deviation 6.39 |
Secondary
Number of Dressing Changes
Number of dressing changes including first assembly
Time frame: 4 weeks
Population: ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mepilex Ag | Number of Dressing Changes | 3.1 applications | Standard Deviation 1.86 |
| SSD Ag Cream | Number of Dressing Changes | 14.0 applications | Standard Deviation 13 |
Secondary
% of Study Burn Healed After One Week
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mepilex Ag | % of Study Burn Healed After One Week | 44.3 percentage of study burn healed | Standard Deviation 37.4 |
| SSD Ag Cream | % of Study Burn Healed After One Week | 27.0 percentage of study burn healed | Standard Deviation 30.7 |
Secondary
Percent of Burn Epithelised/Healed
Healing will be defined as 95% or more epithelialisation
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mepilex Ag | Percent of Burn Epithelised/Healed | 87.1 percentage of study burn healed | Standard Deviation 29 |
| SSD Ag Cream | Percent of Burn Epithelised/Healed | 85.2 percentage of study burn healed | Standard Deviation 27.8 |