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

NCT00297752 | Completed Phase 4

• 1 other identifier: WO/PO.109
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 3

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.

Conditions

Burns

Keywords

facial burns; cerium flammazine; quality of life; randomised clinical trial

Outcome Measures

Primary Outcomes (4)

• Regarding the efficacy of treatment

  time to wound healing

  3 weeks

• * number of patients requiring surgical excision of their facial burns

  number of patients requiring surgical treatment for healing of facial burns

  6 weeks

• Regarding psychosocial impact:

  discrepancy between patient and observer scar assessment

  3 months

• * quality of life and self esteem

  measurement of self esteem related to scar quality

  6 months post burn

Secondary Outcomes (5)

• ● quality of scar (patient and observer)

  12 months post burn

• ● scar elasticity, vascularisation and pigmentation,

  12 months post burn

• ● hypertrophic surface area

  12 months post burn

• ● functional and/or anatomic impairments,

  12 months post burn

• ● mimic function

  12 months post burn

Study Arms (2)

'ceriumnitrate silversulfadiazine (flammacerium)

ACTIVE COMPARATOR

facial burns treatment with Cerium nitrate silver sulfadiazine

Drug: ceriumnitrate silversulfadiazine (flammacerium)

flammazine

ACTIVE COMPARATOR

facial burns treatment with silver sulfadiazine

Drug: silversulfadiazine (flammazine)

Interventions

ceriumnitrate silversulfadiazine (flammacerium) DRUG

treatment of patients with facial burns with CE-SSD

Also known as: CE-SSD

'ceriumnitrate silversulfadiazine (flammacerium)

silversulfadiazine (flammazine) DRUG

treatment of patients with facial burns with SSD

Also known as: SSD

flammazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association of Dutch Burn Centres: lead
• Dutch Burns Foundation: collaborator

Study Sites (3)

Red Cross Hopsital, Burns Centre

Beverwijk, 1942 LE, Netherlands

Location

Martini Hospital, Burns centre

Groningen, 9728 NZ, Netherlands

Location

Medical Centre Rijnmond South, Burns centre

Rotterdam, 3075 EA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 22842424 DERIVED

MeSH Terms

Conditions

Burns

Interventions

cerous nitrate, sulfadiazine silver drug combination; Silver Sulfadiazine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfadiazine; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Nancy van Loey, PhD

  Association of Dutch Burns Centres

  PRINCIPAL INVESTIGATOR

• Marianne K Nieuwenhuis, PhD

  Association of Dutch Burn Centres

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 1, 2006
• Study Start: March 1, 2006
• Study Completion: December 1, 2008
• Last Updated: February 17, 2020

Record last verified: 2009-08

Locations

NL (3)