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Table 2 Time schedule for study procedures and assessments

From: Clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns: study protocol for a randomized controlled trial

Procedure/Assessment Admission Treatment phase Follow-up (month)
    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 7th ±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
  1. LDI laser Doppler imaging, PBD post-burn day