Clinical trial NCT00297752: Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Burns
Keywords: facial burns
cerium flammazine
quality of life
randomised clinical trial
Lead sponsor: Association of Dutch Burn Centres
Sponsor class: OTHER
Collaborators: name: Dutch Burns Foundation
First posted: 2006-03-01
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Regarding the efficacy of treatment
timeFrame: 3 weeks
measure: * number of patients requiring surgical excision of their facial burns
timeFrame: 6 weeks
measure: Regarding psychosocial impact:
timeFrame: 3 months
measure: * quality of life and self esteem
timeFrame: 6 months post burn
Secondary outcomes:
measure: ● quality of scar (patient and observer)
timeFrame: 12 months post burn
measure: ● scar elasticity, vascularisation and pigmentation,
timeFrame: 12 months post burn
measure: ● hypertrophic surface area
timeFrame: 12 months post burn
measure: ● functional and/or anatomic impairments,
timeFrame: 12 months post burn
measure: ● mimic function
timeFrame: 12 months post burn
Other outcomes:
Locations:
city: Beverwijk
country: Netherlands
facility: Red Cross Hopsital, Burns Centre
city: Groningen
country: Netherlands
facility: Martini Hospital, Burns centre
city: Rotterdam
country: Netherlands
facility: Medical Centre Rijnmond South, Burns centre
Study officials:
affiliation: Association of Dutch Burns Centres
name: Nancy van Loey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Association of Dutch Burn Centres
name: Marianne K Nieuwenhuis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oen IMMH, van Baar ME, Middelkoop E, Nieuwenhuis MK. 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. doi: 10.1097/PRS.0b013e3182589d63.