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

This study has been completed.
Sponsor:
Collaborator:
Dutch Burns Foundation
Information provided by:
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT00297752
First received: February 28, 2006
Last updated: August 7, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Burns
Drug: ceriumnitrate silversulfadiazine (flammacerium)
Drug: silversulfadiazine (flammazine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Association of Dutch Burn Centres:

Primary Outcome Measures:
  • Regarding the efficacy of treatment
  • * number of patients requiring surgical excision of their facial burns
  • Regarding psychosocial impact:
  • * quality of life and self esteem

Secondary Outcome Measures:
  • ● quality of scar (patient and observer)
  • ● scar elasticity, vascularisation and pigmentation,
  • ● hypertrophic surface area
  • ● functional and/or anatomic impairments,
  • ● mimic function

Estimated Enrollment: 180
Study Start Date: March 2006
Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297752

Locations
Netherlands
Red Cross Hopsital, Burns Centre
Beverwijk, Netherlands, 1942 LE
Martini Hospital, Burns centre
Groningen, Netherlands, 9728 NZ
Medical Centre Rijnmond South, Burns centre
Rotterdam, Netherlands, 3075 EA
Sponsors and Collaborators
Association of Dutch Burn Centres
Dutch Burns Foundation
Investigators
Principal Investigator: Nancy van Loey, PhD Association of Dutch Burns Centres
Principal Investigator: Marianne K Nieuwenhuis, PhD Association of Dutch Burn Centres
  More Information

No publications provided by Association of Dutch Burn Centres

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00297752     History of Changes
Other Study ID Numbers: WO/PO.109
Study First Received: February 28, 2006
Last Updated: August 7, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Association of Dutch Burn Centres:
facial burns
cerium flammazine
quality of life
randomised clinical trial

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Silver Sulfadiazine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014