Trial Outcomes & Findings for Continuous Antibiotic Prophylaxis in Colorectal Surgery (NCT NCT02445859)

Results Overview

Superficial and deep surgical site infections as defined by the CDC (Centre's for Disease Control) definitions of surgical site infections.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

Number of patients with a surgical site infection within 30 days of a colorectal surgical procedure.

Results posted on

2019-10-10

Participant milestones
Measure	Standard Regimen Cefuroxime 1.5grams pre-operatively Repeated every 4 hours Cefuroxime bolus-continuous infusion: Cefuroxime 1.5 grams pre-operatively, repeated 4 hourly during surgery.	Interventional Regimen Cefuroxime continuous infusion targeting 64mg/l serum concentrations. Cefuroxime 4 hourly bolus: Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L.
Overall Study STARTED	45	45
Overall Study COMPLETED	43	42
Overall Study NOT COMPLETED	2	3

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Standard Dosing n=45 Participants Intravenous (IV) cefuroxime 1.5g bolus administered four-hourly throughout surgery	Intervention Dosing n=45 Participants Cefuroxime bolus-continuous dosing was based on targeting non-protein bound (free) serum concentrations of antibiotic at 64mg/L throughout surgery	Total n=90 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 17 • n=45 Participants	61 years STANDARD_DEVIATION 17 • n=45 Participants	60 years STANDARD_DEVIATION 17 • n=90 Participants
Sex: Female, Male Female	24 Participants n=45 Participants	27 Participants n=45 Participants	51 Participants n=90 Participants
Sex: Female, Male Male	21 Participants n=45 Participants	18 Participants n=45 Participants	39 Participants n=90 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

Timeframe: Number of patients with a surgical site infection within 30 days of a colorectal surgical procedure.

Superficial and deep surgical site infections as defined by the CDC (Centre's for Disease Control) definitions of surgical site infections.

Outcome measures
Measure	Standard Regimen n=43 Participants Cefuroxime 1.5grams pre-operatively Repeated every 4 hours Cefuroxime bolus-continuous infusion: Cefuroxime 1.5 grams pre-operatively, repeated 4 hourly during surgery.	Interventional Regimen n=42 Participants Cefuroxime continuous infusion targeting 64mg/l serum concentrations. Cefuroxime 4 hourly bolus: Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L.
Number of Patients With a Surgical Site Infection	10 Participants	13 Participants

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Standard Regimen n=43 participants at risk Cefuroxime 1.5grams pre-operatively Repeated every 4 hours Cefuroxime bolus-continuous infusion: Cefuroxime 1.5 grams pre-operatively, repeated 4 hourly during surgery.	Interventional Regimen n=42 participants at risk Cefuroxime continuous infusion targeting 64mg/l serum concentrations. Cefuroxime 4 hourly bolus: Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L.
Gastrointestinal disorders Anastomotic leak	0.00% 0/43 • 30 days	7.1% 3/42 • Number of events 3 • 30 days
Gastrointestinal disorders Unplanned surgical procedure	2.3% 1/43 • Number of events 1 • 30 days	4.8% 2/42 • Number of events 2 • 30 days
Gastrointestinal disorders Gastrointestinal bleed	2.3% 1/43 • Number of events 1 • 30 days	0.00% 0/42 • 30 days
Gastrointestinal disorders Pleural effusion with pleural drain insertion	2.3% 1/43 • Number of events 1 • 30 days	0.00% 0/42 • 30 days

Other adverse events
Measure	Standard Regimen n=43 participants at risk Cefuroxime 1.5grams pre-operatively Repeated every 4 hours Cefuroxime bolus-continuous infusion: Cefuroxime 1.5 grams pre-operatively, repeated 4 hourly during surgery.	Interventional Regimen n=42 participants at risk Cefuroxime continuous infusion targeting 64mg/l serum concentrations. Cefuroxime 4 hourly bolus: Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L.
Gastrointestinal disorders Clostridium difficile infection	0.00% 0/43 • 30 days	0.00% 0/42 • 30 days

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