A randomized clinical trial on the effectiveness, cost-effectiveness and quality of life of Flaminal® versus Flammazine® in the treatment of superficial and deep partial thickness burns.

Completed

Conditions: kwaliteit van leven
partial thickness burns
second degree burns
10014982
10040795

Registration Number: NL-OMON40281

Lead Sponsor: Rode Kruis Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

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

Exclusion Criteria

- Age < 18 years
- Total body surface area (TBSA) of > 30% (excluding head)
- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is time to reach complete re-epithelialization (>95%) in days<br /><br>of the largest partial thickness burn area (study area), judged by an<br /><br>experienced burn specialist/ trained researcher.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Clinical outcomes: Need for operation and percentage of TBSA of the study area<br /><br>that needs operation, colonization rate, infection rate, use of systematic<br /><br>antibiotics.<br /><br>-Patients outcomes:<br /><br>Pain and anxiety: Visual Analogue Thermometer (VAT) and Burn Specific Pain<br /><br>Anxiety Scale (BSPAS) are used to evaluate pain and anxiety for the treatment.<br /><br>Health related quality of life (HRQoL): Burn Specific Health Scale (BSHS) -<br /><br>Dutch and EuroQol -5D questionnaire are evaluated 3, 6 and 12 months post burn<br /><br>to evaluate HRQoL.<br /><br>Scarring: Patient and Observer Scar Assessment Score (POSAS), cutometer to<br /><br>measure scar elasticity and dermaspectometer to assess scar colour are used 3,<br /><br>6 and 12 month post-burn to evaluate scarring.<br /><br>-Cost-effectiveness: Medical and non-medical of both treatments are evaluated.</p><br>