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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
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