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

This study has been completed.
Sponsor:
Collaborator:
Dutch Burns Foundation
Information provided by:
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT00297752
First received: February 28, 2006
Last updated: August 7, 2009
Last verified: August 2009

February 28, 2006
August 7, 2009
March 2006
Not Provided
  • Regarding the efficacy of treatment
  • * number of patients requiring surgical excision of their facial burns
  • Regarding psychosocial impact:
  • * quality of life and self esteem
Same as current
Complete list of historical versions of study NCT00297752 on ClinicalTrials.gov Archive Site
  • ● quality of scar (patient and observer)
  • ● scar elasticity, vascularisation and pigmentation,
  • ● hypertrophic surface area
  • ● functional and/or anatomic impairments,
  • ● mimic function
Same as current
Not Provided
Not Provided
 
Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burns
  • Drug: ceriumnitrate silversulfadiazine (flammacerium)
  • Drug: silversulfadiazine (flammazine)
Not Provided
Oen IM, van Baar ME, Middelkoop E, Nieuwenhuis MK; Facial Burns Group. 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2008
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00297752
WO/PO.109
Not Provided
Not Provided
Association of Dutch Burn Centres
Dutch Burns Foundation
Principal Investigator: Nancy van Loey, PhD Association of Dutch Burns Centres
Principal Investigator: Marianne K Nieuwenhuis, PhD Association of Dutch Burn Centres
Association of Dutch Burn Centres
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP