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Table 1 Clinical trial schedule

From: APOS—antibiotic prophylaxis for preventing infectious complications in orthognathic surgery: study protocol for a phase III, multicentre, randomised, controlled, double blinded, clinical trial with two parallel study arms

Visit no.   V1 V2   V3   V4 V5 V6 V7 V8
Phase   Screening/baseline   Treatment Follow up
Relative time point Day D-28 to D-1
Pre-surgery visit/hospital admissiona
D0 POD1 POD2 POD3 POD4 POD 10 ± 3 days POD 30 ± 3 days POD 60 ± 3 days POD 90 ± 3 days
Pre-OS Pos-OS
Procedure             
Inclusion/ exclusion criteria C           
Written informed consent C           
Medical history, demography R e           
Randomisation C b           
Surgery             
dIMP administration C        
Examination of mouth cavity R e           
Mouth hygiene R      
fSSI R       
gPregnancy test C c           
hBlood tests:
CRP, WBC
R c           
HRQoL:SF-36,
OHIP-G-14
C          
iAE R   
jConcomitant medication R  
kPostoperative pain medication R      
Smoking and/or alcohol consumption R    
  1. R regular or C clinical trial specific examination; POD postoperative day; OS orthognathic surgery; V visit
  2. aRoutine pre-surgery information visit approx. 3–4 weeks before OS; routine hospital admission: D-1
  3. bRandomisation: D-1 or earlier when subject eligibility confirmed and IC obtained
  4. cLab tests at hospital admission D-1
  5. dIMP administration: Total of 12 doses will be administered during treatment phase (D0–POD4) over a period of 96 h
  6. ePathological findings detected prior to the 1st administration of IMP are to be documented as medical history, thereafter as adverse events
  7. fSSI: post-op. evaluation of mouth cavity for signs and symptoms for SSI
  8. gIn females of child-bearing potential; performed in blood (HCG) or urine
  9. hBlood tests: C-reactive protein (CRP) and WBC count. If SSI is diagnosed independent of trial visits, an additional blood sample is taken
  10. iAE/SAE: adverse/serious adverse events. Pathological findings detected at/after the first administration of IMP are to be documented as AE/SAE
  11. jConcomitant medication: prior concomitant medication (inclusive pre-operative medication, exclusive intraoperative medication)
  12. kPostoperative pain medication as needed till POD30 to be documented