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| Name | Class |
|---|---|
| Dutch Burns Foundation | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 'ceriumnitrate silversulfadiazine (flammacerium) | Active Comparator | facial burns treatment with Cerium nitrate silver sulfadiazine |
|
| flammazine | Active Comparator | facial burns treatment with silver sulfadiazine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceriumnitrate silversulfadiazine (flammacerium) | Drug | treatment of patients with facial burns with CE-SSD |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy van Loey, PhD | Association of Dutch Burns Centres | Principal Investigator |
| Marianne K Nieuwenhuis, PhD | Association of Dutch Burn Centres | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red Cross Hopsital, Burns Centre | Beverwijk | 1942 LE | Netherlands | |||
| Martini Hospital, Burns centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22842424 | Derived | Oen IMMH, van Baar ME, Middelkoop E, Nieuwenhuis MK. Effectiveness of cerium nitrate-silver sulfadiazine in the treatment of facial burns: a multicenter, randomized, controlled trial. Plast Reconstr Surg. 2012 Aug;130(2):274e-283e. doi: 10.1097/PRS.0b013e3182589d63. |
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| silversulfadiazine (flammazine) | Drug | treatment of patients with facial burns with SSD |
|
|
| 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 |
| Groningen |
| 9728 NZ |
| Netherlands |
| Medical Centre Rijnmond South, Burns centre | Rotterdam | 3075 EA | Netherlands |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C046337 | cerous nitrate, sulfadiazine silver drug combination |
| D012837 | Silver Sulfadiazine |
| ID | Term |
|---|---|
| D013411 | Sulfadiazine |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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