Flaminal® versus Flammazine® in the treatment of superficial and deep partial thickness burns (Flam study)

Recruiting

Conditions: Flammazine®, Flaminal®, wound healing, partial thickness burnsFlammazine®, Flaminal®, wondgenezing, tweedegraads brandwonden

Registration Number: NL-OMON27618

Lead Sponsor: eiden University Medical Center (LUMC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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 >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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
-Clinical outcomes: Need for operation and percentage of TBSA of the study area that needs operation, colonization rate, infection rate, use of systematic antibiotics. <br /><br>-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. <br /><br>-Cost-effectiveness: Medical and non-medical of both treatments are evaluated.