Burns, Burn Scar, Burn Second Degree
Conditions
Brief summary
The purpose of this study was to compare two wound dressing products for partial thickness burns in adults.
Detailed description
After being informed about the study, all patients that had given written informed consent underwent screening. If eligible study participants were randomized to be treated wih either the standard dressing of care; pigskin or a microbial cellulose. Dressing were applied within 72 hours after burn injury. Evaluation was done in an open manner due to the specific characteristics of the dressings. Study particpants were followed weekly until complete wound closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.
Interventions
OTHERmicrobial cellulose
polymer dressing synthesized in abundance with Acetobacter Xylinum
Sponsors
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Study participants admitted within 72 hours of injury * partial-thickness burns requiring a temporary skin cover * written informed consent
Exclusion criteria
* severe coexisting cutaneous trauma * chronic or current skin disease, * severe cognitive dysfunction or psychiatric disorder * pregnant or breast feeding women were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete healing of the burn | Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months | Healing time was calculated from the date of injury to the date when the wound bed was assessed as completely (100 %) re-epithelialized, with no need for further dressing changes other than protection against shearing according to the treating physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burn wound infection | Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months | Wound infections were diagnosed (by the burn surgeon) if they fulfilled at least two of the following criteria: (based on the American Burn Association definition of burn wound infection) * Clinical signs such as localised pain and swelling, spreading erythema, and heat at the affected site. * Positive bacterial culture growth of the surface wound swab. * Signs of systemic infection indicated by a rise in CRP concentration (reference range \< 10 mg/L for capillary sampling) together with increased body temperature where other sources of infection have been excluded. |
| Burn wound pain | Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months | The patients were asked to estimate the burn wound pain at rest, during activity, and during dressing changes using a numerical rating scale (NRS) where 0 indicated no pain and 10 the worst pain ever imaginable. |
| Duration of hospital stay (LOS) | From admission until discharge, up to 6 months | All patients hospitalized for their burns were monitored by the study nurse and the day of discharge was noted in the CRF. Any readmission after initial discharge was also noted and included in the total length of stay. |
| Burn scar outcome | Evaluated at six and 12 months after injury | Burn scar outcome was evaluated using the Patient Observer Scar Assessment Scale (POSAS). The scale includes two separate subscales, The Observer Sscale, used by an experienced burn occupational therapist and the Patient Sscale, used by the study participants. |
Countries
Sweden
Outcome results
None listed