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

Table 1 Clinical trial schedule

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 admission^a	D0		POD1	POD2	POD3	POD4	POD 10 ± 3 days	POD 30 ± 3 days	POD 60 ± 3 days	POD 90 ± 3 days
Relative time point	Day	D-28 to D-1 Pre-surgery visit/hospital admission^a	Pre-OS	Pos-OS	POD1	POD2	POD3	POD4	POD 10 ± 3 days	POD 30 ± 3 days	POD 60 ± 3 days	POD 90 ± 3 days
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	●				●	●	●	●	●	●	●

R regular or C clinical trial specific examination; POD postoperative day; OS orthognathic surgery; V visit
^aRoutine pre-surgery information visit approx. 3–4 weeks before OS; routine hospital admission: D-1
^bRandomisation: D-1 or earlier when subject eligibility confirmed and IC obtained
^cLab tests at hospital admission D-1
^dIMP administration: Total of 12 doses will be administered during treatment phase (D0–POD4) over a period of 96 h
^ePathological findings detected prior to the 1st administration of IMP are to be documented as medical history, thereafter as adverse events
^fSSI: post-op. evaluation of mouth cavity for signs and symptoms for SSI
^gIn females of child-bearing potential; performed in blood (HCG) or urine
^hBlood tests: C-reactive protein (CRP) and WBC count. If SSI is diagnosed independent of trial visits, an additional blood sample is taken
ⁱAE/SAE: adverse/serious adverse events. Pathological findings detected at/after the first administration of IMP are to be documented as AE/SAE
^jConcomitant medication: prior concomitant medication (inclusive pre-operative medication, exclusive intraoperative medication)
^kPostoperative pain medication as needed till POD30 to be documented

ISSN: 1745-6215