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Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing
This study is currently recruiting participants.
Verified by Association of Dutch Burn Centres, October 2007
Sponsors and Collaborators: Association of Dutch Burn Centres
Dutch Burns Foundation
Information provided by: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT00297752
  Purpose

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.


Condition Intervention Phase
Burns
Drug: ceriumnitrate silversulfadiazine (flammacerium)
Drug: silversulfadiazine (flammazine)
Phase IV

MedlinePlus related topics: Burns Scars
Drug Information available for: Silver sulfadiazine Cerium-flamazine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Association of Dutch Burn Centres:

Primary Outcome Measures:
  • Regarding the efficacy of treatment
  • * number of patients requiring surgical excision of their facial burns
  • Regarding psychosocial impact:
  • * quality of life and self esteem

Secondary Outcome Measures:
  • ● quality of scar (patient and observer)
  • ● scar elasticity, vascularisation and pigmentation,
  • ● hypertrophic surface area
  • ● functional and/or anatomic impairments,
  • ● mimic function

Estimated Enrollment: 180
Study Start Date: March 2006
Estimated Study Completion Date: August 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297752

Locations
Netherlands
Martini Hospital, Burns centre Recruiting
Groningen, Netherlands, 9728 NZ
Contact: Marianne K Nieuwenhuis, PhD     +31 (0)50-5245245 ext 5565     m.k.nieuwenhuis@mzh.nl    
Principal Investigator: Marianne K Nieuwenhuis, PhD            
Red Cross Hopsital, Burns Centre Recruiting
Beverwijk, Netherlands, 1942 LE
Contact: Antoon J van den Bogaerdt, PhD     + 31 (0)251-265555 ext 4917     avdbogaerdt@burns.nl    
Principal Investigator: Antoon J van den Bogaerdt, PhD            
Medical Centre Rijnmond South, Burns centre Recruiting
Rotterdam, Netherlands, 3075 EA
Contact: Irma M. Oen, M.D.     +31 (0)10 290 30 00 ext 3135     oeni@mcrz.nl    
Principal Investigator: Irma M. Oen, M.D.            
Sponsors and Collaborators
Association of Dutch Burn Centres
Dutch Burns Foundation
Investigators
Principal Investigator: Nancy van Loey, PhD Association of Dutch Burns Centres
Principal Investigator: Marianne K Nieuwenhuis, PhD Association of Dutch Burn Centres
  More Information

Study ID Numbers: WO/PO.109
Study First Received: February 28, 2006
Last Updated: October 22, 2007
ClinicalTrials.gov Identifier: NCT00297752  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Association of Dutch Burn Centres:
facial burns
cerium flammazine
quality of life
randomised clinical trial

Study placed in the following topic categories:
Burns
Facies
Silver Sulfadiazine
Wounds and Injuries
Quality of Life
Disorders of Environmental Origin
Sulfadiazine

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009