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

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297752
• Other study ID #: WO/PO.109
• Status: Completed
• Phase: Phase 4
• Start date: March 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Association of Dutch Burn Centres
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• ceriumnitrate silversulfadiazine (flammacerium)
treatment of patients with facial burns with CE-SSD
• silversulfadiazine (flammazine)
treatment of patients with facial burns with SSD

Locations

Country	Name	City	State
Netherlands	Red Cross Hopsital, Burns Centre	Beverwijk
Netherlands	Martini Hospital, Burns centre	Groningen
Netherlands	Medical Centre Rijnmond South, Burns centre	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Association of Dutch Burn Centres	Dutch Burns Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regarding the efficacy of treatment	time to wound healing	3 weeks
Primary	* number of patients requiring surgical excision of their facial burns	number of patients requiring surgical treatment for healing of facial burns	6 weeks
Primary	Regarding psychosocial impact:	discrepancy between patient and observer scar assessment	3 months
Primary	* quality of life and self esteem	measurement of self esteem related to scar quality	6 months post burn
Secondary	? quality of scar (patient and observer)	scar assessment by patient and observer scar scale	12 months post burn
Secondary	? scar elasticity, vascularisation and pigmentation,	scar assessment by cutometer and dermaspectrometer	12 months post burn
Secondary	? hypertrophic surface area	scar thickness area	12 months post burn
Secondary	? functional and/or anatomic impairments,	descriptive analysis	12 months post burn
Secondary	? mimic function	physical examination	12 months post burn