Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297752
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2006-02-28
Brief Title:
Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing
Sponsor:
Association of Dutch Burn Centres
Organization:
Association of Dutch Burn Centres
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients personal needs
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 patients personal needs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None