Table 2 Time schedule for study procedures and assessments

3

6

12

Standard screening, baseline procedures

x

Check eligibility (inclusion criteria)

x

Provide patient Information

x

Obtain written informed consent

x

x (confirmation by patients who were initially non-competent)

Randomization (Flaminal® vs Flamazine®)

x

Baseline parameters

x

LDI

x

Wound colonization

x

x

Wound healing

At each dressing change

Need for surgery of partial and/or full thickness burns and % of study area requiring skin graft

10–14 PBD

Colonization

x

Swabs on Mondays and Thursdays

Infection

x

Clinical judgment during dressing changes

Dressing changes

x

Use of systemic antibiotics

x

Pain and anxiety

 Visual analogue thermometer (VAT)

x

Daily, before and after dressing change and in the evening

 Itching

x

Daily in the evening on 7^th ±2 PBD and day of discharge

 Burn Specific Pain and Anxiety Score (BSPAS)

x

Health-related quality of life (HRQoL)

In the last week of hospitalization

 Burn Specific Health Scale Brief (BSHS-Brief)

In the last week of hospitalization

x

x

x

 EuroQol-5D (EQ-5D)

x

x

x

Scarring

 POSAS

x

x

x

 Cutometry

x

x

x

 Dermaspectrometry

x

x

x

Costs

Daily

x

x

x