NCT00297752

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

Completed Phase 4 Last updated 13 February 2020

What this trial tests

Phase 4 trial testing ceriumnitrate silversulfadiazine (flammacerium) in Burns in 154 participants. Completed in 1 December 2008.

Timeline

1 March 2006

1 December 2008

Quick facts

Lead sponsor	Association of Dutch Burn Centres
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	154
Start date	1 March 2006
Estimated completion	1 December 2008
Sites	3 locations across Netherlands

Drugs / interventions tested

• ceriumnitrate silversulfadiazine (flammacerium) — full drug profile →
• silversulfadiazine (flammazine) — full drug profile →

Conditions studied

• Burns — all drugs for Burns →

Sponsor

Association of Dutch Burn Centres

Who can join

18 and older, any sex, with Burns. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Regarding the efficacy of treatment
  Time frame: 3 weeks
  time to wound healing
• * number of patients requiring surgical excision of their facial burns
  Time frame: 6 weeks
  number of patients requiring surgical treatment for healing of facial burns
• Regarding psychosocial impact:
  Time frame: 3 months
  discrepancy between patient and observer scar assessment
• * quality of life and self esteem
  Time frame: 6 months post burn
  measurement of self esteem related to scar quality

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.