Burns
Conditions
Keywords
facial burns, cerium flammazine, quality of life, randomised clinical trial
Brief summary
The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres. Scarring of the face as a consequence of burns will often have a detrimental effect on function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing. In clinical practice good results are felt to be achieved by treatment of facial burns with flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is compared to flammazine, a current alternative of care. The efficacy of treatment will be assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in terms of number of patients requiring surgery and functional and aesthetic outcome. Apart from medical outcome, this study offers the opportunity to study psychosocial problems associated with facial defects. It is still an unresolved question whether facial scarring causes more or different psychosocial problems. Therefore, self-esteem and quality of life will be examined over time, in relation to depression, posttraumatic stress symptoms and other factors, such as coping style and social support. By evaluating the efficacy of different treatment strategies, we aim to optimise the standard of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial impact of facial injury. With these results psychosocial professionals will be able to focus on persons at risk and to be better able to meet a patient's personal needs.
Interventions
DRUGceriumnitrate silversulfadiazine (flammacerium)
treatment of patients with facial burns with CE-SSD
DRUGsilversulfadiazine (flammazine)
treatment of patients with facial burns with SSD
Sponsors
Dutch Burns Foundation
Association of Dutch Burn Centres
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
* patients of 18 years of age or older, competent or temporarily incompetent, who are admitted to one of the three dedicated Dutch Burn Centres with burn injuries involving the face
Exclusion criteria
* patients not seen within 24 hours postburn * patients with mental or cognitive deficits that may interfere with providing informed consent * patients with poor Dutch proficiency * patients with chemical burns
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regarding the efficacy of treatment | 3 weeks | time to wound healing |
| * number of patients requiring surgical excision of their facial burns | 6 weeks | number of patients requiring surgical treatment for healing of facial burns |
| Regarding psychosocial impact: | 3 months | discrepancy between patient and observer scar assessment |
| * quality of life and self esteem | 6 months post burn | measurement of self esteem related to scar quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ● quality of scar (patient and observer) | 12 months post burn | scar assessment by patient and observer scar scale |
| ● mimic function | 12 months post burn | physical examination |
| ● scar elasticity, vascularisation and pigmentation, | 12 months post burn | scar assessment by cutometer and dermaspectrometer |
| ● hypertrophic surface area | 12 months post burn | scar thickness area |
| ● functional and/or anatomic impairments, | 12 months post burn | descriptive analysis |
Countries
Netherlands
Outcome results
None listed