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

Phase 4

Completed

• Conditions: Burns
• Interventions: Drug: ceriumnitrate silversulfadiazine (flammacerium); Drug: silversulfadiazine (flammazine)

• Registration Number: NCT00297752
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-28
• Study First Submitted QC: 2006-02-28
• Study Start: 2006-03
• Study First Posted: 2006-03-01
• Study Completion: 2008-12
• Status Verified: 2009-08
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'ceriumnitrate silversulfadiazine (flammacerium)	ceriumnitrate silversulfadiazine (flammacerium)	facial burns treatment with Cerium nitrate silver sulfadiazine
flammazine	silversulfadiazine (flammazine)	facial burns treatment with silver sulfadiazine

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
● hypertrophic surface area	12 months post burn	scar thickness area
● quality of scar (patient and observer)	12 months post burn	scar assessment by patient and observer scar scale
● scar elasticity, vascularisation and pigmentation,	12 months post burn	scar assessment by cutometer and dermaspectrometer
● functional and/or anatomic impairments,	12 months post burn	descriptive analysis
● mimic function	12 months post burn	physical examination

Trial Locations

Locations (3)

Martini Hospital, Burns centre; 🇳🇱 Groningen, Netherlands

Red Cross Hopsital, Burns Centre; 🇳🇱 Beverwijk, Netherlands

Medical Centre Rijnmond South, Burns centre; 🇳🇱 Rotterdam, Netherlands