Patients with partial thickness burns and/ or mixed depth of partial and full thickness burns MedDRA version: 14.1 Level: LLT Classification code 10015723 Term: Extensive burns System Organ Class: 100000004863 MedDRA version: 14.1 Level: LLT Classification code 10006796 Term: Burns eyes System Organ Class: 100000004863 MedDRA version: 14.1 Level: LLT Classification code 10006795 Term: Burns extensive System Organ Class: 100000004863 MedDRA version: 16.0 Level: LLT Classification code 1000679
Conditions
Interventions
Trade Name: Flammazine®
Product Name: Flammazine
Pharmaceutical Form: Cream
INN or Proposed INN: SULFADIAZINE SILVER
CAS Number: 22199-08-2
Current Sponsor code: 12345
Other descriptive name: Flammazi
Sponsors
Rode Kruis Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Competent or temporary incompetent (because of sedation and/ or intubation) patients with partial thickness burns and/ or mixed depth of partial and full thickness burns - Hospital admission within 48 hour of burn injury - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Age 20% - Burns caused by chemicals, electricity or radiation - Patients in whom local therapy with a topical agent has already started - Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness, cost-effectiveness and quality of life of Flaminal® versus Flammazine® in the treatment of superficial and deep partial thickness burns.;Secondary Objective: -Clinical outcomes: Need for operation and percentage of TBSA of the study area that needs operation, colonization rate, infection rate, use of systematic antibiotics. -Patients outcomes: Pain and anxiety: Visual Analogue Thermometer (VAT) and Burn Specific Pain Anxiety Scale (BSPAS) are used to evaluate pain and anxiety for the treatment. Health related quality of life (HRQoL): Burn Specific Health Scale (BSHS) – Dutch and EuroQol -6D questionnaire are evaluated 3, 6 and 12 months post burn to evaluate HRQoL. Scarring: Patient and Observer Scar Assessment Score (POSAS), cutometer to measure scar elasticity and dermaspectometer to assess scar colour are used 3, 6 and 12 month post-burn to evaluate scarring. -Cost-effectiveness: Medical and non-medical of both treatments are evaluated. ;Primary end point(s): Primary endpoint is time to reach complete re-epithelialization (>95%) in days of the largest partial thickness burn area (study area), judged by an experienced burn specialist/ trained researcher;Timepoint(s) of evaluation of this end point: During dressings change | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Clinical outcomes: Need for operation and percentage of TBSA of the study area that needs operation, colonization rate, infection rate, use of systematic antibiotics. -Patients outcomes: Pain and anxiety: Visual Analogue Thermometer (VAT) and Burn Specific Pain Anxiety Scale (BSPAS) are used to evaluate pain and anxiety for the treatment. Health related quality of life (HRQoL): Burn Specific Health Scale (BSHS) – Dutch and EuroQol -6D questionnaire are evaluated 3, 6 and 12 months post burn to evaluate HRQoL. Scarring: Patient and Observer Scar Assessment Score (POSAS), cutometer to measure scar elasticity and dermaspectometer to assess scar colour are used 3, 6 and 12 month post-burn to evaluate scarring. -Cost-effectiveness: Medical and non-medical of both treatments are evaluated.;Timepoint(s) of evaluation of this end point: -Clinical outcomes: daily -Patients outcomes: Pain and anxiety: Visual Analogue Thermometer (VAT) and Burn Specific Pain Anxiety Scale (BSPAS) are used to evaluate pain and anxiety for the treatment. Health related quality of life (HRQoL): Burn Specific Health Scale (BSHS) – Dutch and EuroQol -6D questionnaire are evaluated 3, 6 and 12 months post burn to evaluate HRQoL. Scarring: Patient and Observer Scar Assessment Score (POSAS), cutometer to measure scar elasticity and dermaspectometer to assess scar colour are used 3, 6 and 12 month post-burn to evaluate scarring. -Cost-effectiveness: Medical and non-medical of both treatments are evaluated. | — |
Countries
Netherlands
Contacts
Public ContactZ.M. Rashaan
Rode Kruis Ziekenhuis
Outcome results
None listed