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Intravenous versus combined oral and intravenous antimicrobial prophylaxis for the prevention of surgical site infection in elective colorectal surgery: A double-blinded multicenter prospective randomized controlled trial - COMBINE Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002559-84-FR

Enrollment

920

Registered

2015-08-05

Start date

2015-07-29

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: TIBERAL Pharmaceutical Form: Coated tablet INN or Proposed INN: ORNIDAZOLE CAS Number: 16773-42-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 620 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: .

Design outcomes

Primary

Measure	Time frame
Main Objective: .;Secondary Objective: .;Primary end point(s): .;Timepoint(s) of evaluation of this end point: .	—

Secondary

Measure	Time frame
Secondary end point(s): - To determine the relationship between the antibiotic prophylaxis strategy and the incidence of individual types of SSI (superficial incision infection, deep incision infection and organ-space infection) within 30 days after surgery - To determine the safety of antibiotic prophylaxis (clinical adverse events) - To describe the effect of SSI on postoperative complications, surgical reintervention, duration of hospital stay and postoperative mortality - To determine the relationship between SSI and the time to introduction of adjuvant chemotherapy ;Timepoint(s) of evaluation of this end point: .	—

Measure

Time frame

Secondary end point(s): - To determine the relationship between the antibiotic prophylaxis strategy and the incidence of individual types of SSI (superficial incision infection, deep incision infection and organ-space infection) within 30 days after surgery - To determine the safety of antibiotic prophylaxis (clinical adverse events) - To describe the effect of SSI on postoperative complications, surgical reintervention, duration of hospital stay and postoperative mortality - To determine the relationship between SSI and the time to introduction of adjuvant chemotherapy ;Timepoint(s) of evaluation of this end point: .

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Countries

France

Contacts

Public ContactDélégation à la recherche clinique

CHU de Clermont-Ferrand

placarin@chu-clermontferrand.fr00330473751195

Outcome results