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

February 13, 2020 updated by: Association of Dutch Burn Centres

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Beverwijk, Netherlands, 1942 LE
        • Red Cross Hopsital, Burns Centre
      • Groningen, Netherlands, 9728 NZ
        • Martini Hospital, Burns centre
      • Rotterdam, Netherlands, 3075 EA
        • Medical Centre Rijnmond South, Burns centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 'ceriumnitrate silversulfadiazine (flammacerium)
facial burns treatment with Cerium nitrate silver sulfadiazine
Drug: ceriumnitrate silversulfadiazine (flammacerium)
treatment of patients with facial burns with CE-SSD
Other Names:
  • CE-SSD
Active Comparator: flammazine
facial burns treatment with silver sulfadiazine
Drug: silversulfadiazine (flammazine)
treatment of patients with facial burns with SSD
Other Names:
  • SSD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association of Dutch Burn Centres

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

February 28, 2006

First Posted (Estimate)

March 1, 2006

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO/PO.109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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