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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297752
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : August 10, 2009
Dutch Burns Foundation
Information provided by:
Association of Dutch Burn Centres

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 patient's personal needs.

Condition or disease Intervention/treatment Phase
Burns Drug: ceriumnitrate silversulfadiazine (flammacerium) Drug: silversulfadiazine (flammazine) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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

Secondary Outcome Measures :
  1. ● quality of scar (patient and observer)
  2. ● scar elasticity, vascularisation and pigmentation,
  3. ● hypertrophic surface area
  4. ● functional and/or anatomic impairments,
  5. ● mimic function

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00297752

Red Cross Hopsital, Burns Centre
Beverwijk, Netherlands, 1942 LE
Martini Hospital, Burns centre
Groningen, Netherlands, 9728 NZ
Medical Centre Rijnmond South, Burns centre
Rotterdam, Netherlands, 3075 EA
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00297752     History of Changes
Other Study ID Numbers: WO/PO.109
First Posted: March 1, 2006    Key Record Dates
Last Update Posted: August 10, 2009
Last Verified: August 2009

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

Additional relevant MeSH terms:
Wounds and Injuries
Silver Sulfadiazine
Anti-Infective Agents, Local
Anti-Infective Agents