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

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 (Flam study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27618

Enrollment

Registered

2014-04-02

Start date

2014-02-04

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flammazine®, Flaminal®, wound healing, partial thickness burns Flammazine®, Flaminal®, wondgenezing, tweedegraads brandwonden

Interventions

Flaminal® Forte: The treatment with Flaminal® Forte (glucose oxidase-lactoperoxidase-guaiacol complex in alginogel, FlenPharma) consists of the application of Flaminal® Forte on admittance (within 48

Eligibility

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

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
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

Measure	Time frame
-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.	—

Measure

Time frame

-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.

—

Contacts

Public ContactZ.M. Rashaan

Principal investigator Red Cross Hospital-Burn Center Postbus 1074

zrashaan@rkz.nl+31 251 264917

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)