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Table 4 Site requirements for potential participation in the COOL study

From: Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial

Minimal system resources required for site participation in COOL-Lite
 - Designated primary investigator presumably with an academic affiliation willing to take overall medical/ethical/academic responsibility for the conduct of the study
- Ethical approval—by the appropriate local ethics committee with oversight of the participating institution
 - Site investigators/willing local surgeons with the responsibility of caring for those with SIAS and thus the ability to recruit patients
 - Internet access—either within or closely available to the operating theater to allow online randomization of patients during laparotomy
 - Negative peritoneal pressure therapy (NPPT) dressing availability for those randomized to OPEN
 - Familiarity with the application of the NPPT device or willingness to undergo training and in service on the safe utilization of the NPPT device
 - Study personnel/investigator capable to record and compile case record and submit to the Central Study Registry
Full system resources required for site participation in COOL-Max
 - Above and also
 - Study personnel capable of obtaining blood/IPF samples
 - Laboratory capability to store frozen blood/IPF fluid till study completion and send to Calgary for analysis
Full system resources required for site participation in COOL-Mic
 - Medical microbiology laboratory capable of basic microbiology studies
 - Medical records and information processing capable of providing microbiology results for study analysis
Full system resources required for site participation in COOL-Cells
 - Geographic proximity to Calgary
 - Ability to collect fresh peritoneal fluid and to rapidly ship to the Snyder laboratory for time-of-flight mass spectrometer
Full system resources required for site participation in COOL-Costs
 - Ability to provide administrative and microcosting data
 - Ability to administrator SF-36 and Euroqol EQ-5D-5L at 90 days and 1 year post enrollment in all survivors