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Completed

NCT Number: NCT00297752

Treatment of Facial Burns With Flammacerium Compared to Flammazine 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Red Cross Hopsital, Burns Centre, Beverwijk, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ceriumnitrate silversulfadiazine (flammacerium)

Drug

treatment of patients with facial burns with CE-SSD

Other names: CE-SSD

silversulfadiazine (flammazine)

Drug

treatment of patients with facial burns with SSD

Other names: SSD

Primary outcomes

  1. Regarding the efficacy of treatment

    Time frame: 3 weeks

    time to wound healing

  2. * 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

  3. Regarding psychosocial impact:

    Time frame: 3 months

    discrepancy between patient and observer scar assessment

  4. * quality of life and self esteem

    Time frame: 6 months post burn

    measurement of self esteem related to scar quality

Secondary outcomes

  1. ● quality of scar (patient and observer)

    Time frame: 12 months post burn

    scar assessment by patient and observer scar scale

  2. ● scar elasticity, vascularisation and pigmentation,

    Time frame: 12 months post burn

    scar assessment by cutometer and dermaspectrometer

  3. ● hypertrophic surface area

    Time frame: 12 months post burn

    scar thickness area

  4. ● functional and/or anatomic impairments,

    Time frame: 12 months post burn

    descriptive analysis

  5. ● mimic function

    Time frame: 12 months post burn

    physical examination

Sponsors and collaborators

Lead sponsor

Association of Dutch Burn Centres

Other

Collaborators

  • Dutch Burns Foundation

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2008
First posted
Mar 1, 2006
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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