Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Multicentre Clinical Trial on the Efficacy of Flammacerium in the Treatment of Facial Burns and the Impact of Facial Burns on Psychosocial Wellbeing

Conditions
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Burns

Intervention / Treatment
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* Drug: ceriumnitrate silversulfadiazine (flammacerium)
* Drug: silversulfadiazine (flammazine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 'ceriumnitrate silversulfadiazine (flammacerium)<br>facial burns treatment with Cerium nitrate silver sulfadiazine | Drug: ceriumnitrate silversulfadiazine (flammacerium)<br>* treatment of patients with facial burns with CE-SSD<br>* Other names: CE-SSD;|
| Active Comparator: flammazine<br>facial burns treatment with silver sulfadiazine | Drug: silversulfadiazine (flammazine)<br>* treatment of patients with facial burns with SSD<br>* Other names: SSD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regarding the efficacy of treatment | time to wound healing | 3 weeks | 
| * number of patients requiring surgical excision of their facial burns | number of patients requiring surgical treatment for healing of facial burns | 6 weeks | 
| Regarding psychosocial impact: | discrepancy between patient and observer scar assessment | 3 months | 
| * quality of life and self esteem | measurement of self esteem related to scar quality | 6 months post burn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ● quality of scar (patient and observer) | scar assessment by patient and observer scar scale | 12 months post burn | 
| ● scar elasticity, vascularisation and pigmentation, | scar assessment by cutometer and dermaspectrometer | 12 months post burn | 
| ● hypertrophic surface area | scar thickness area | 12 months post burn | 
| ● functional and/or anatomic impairments, | descriptive analysis | 12 months post burn | 
| ● mimic function | physical examination | 12 months post burn | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facial burns, cerium flammazine, quality of life, randomised clinical trial