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Funding received for eventual full trial, and data rolled over into full trial. Full trial registered under NCT06567808.
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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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There is clinical equipoise about the question of whether antibiotic prophylaxis should be given for a short period or an extended period of time as reflected by inconsistencies in major guidelines, current practices at Canadian centers, and as concluded in the three systematic reviews. There also is clinical equipoise on whether the addition of vancomycin to routine cefazolin prophylaxis can further reduce s-SSI rates. A short duration of combined antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials such as infections with C. difficile or emergence of resistance, but may also reduce the incidence of s-SSIs. The objective of the eventual full scale study is to determine whether adding vancomycin to cefazolin can reduce SSIs as well as whether short-term prophylaxis is as effective as long-term prophylaxis. The rationale to conduct the proposed pilot study is to assess the feasibility to conduct this factorial cluster randomized cross-over trial, the adherence to the study protocol at each pilot site, the length of time to fill out the case report forms, and to get reliable estimates of event rates for sample size calculation for the main study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefazolin monotherapy, short course | Experimental | One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered |
|
| Cefazolin monotherapy, long course | Experimental | One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose). |
|
| Combination therapy, short course | Experimental | One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered. In addition, one dose of vancomycin 60-90min pre-op will be administered. |
|
| Combination therapy, long course | Experimental | One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose). In addition, one dose of vancomycin 60-90min pre-op will be administered followed by 3 post-op doses every 12 hours (last dose 36 hours after first dose) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefazolin | Drug | administration as outlined |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients receiving antibiotics according to study protocol | Co-Primary outcome of pilot study | 3 months post-surgery |
| Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95% | Co-Primary outcome of pilot study | 3 months post-surgery |
| Agreement of blinded outcome assessment based on information from the case report form | Co-Primary outcome of pilot study | 3 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Deep incisional and organ/space sternal surgical site infection (NHSN/CDC) | Primary outcome of eventual full trial | 3 months post-surgery |
| All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominik Mertz, MD, MSc | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada | ||
| St. Michael's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30558680 | Derived | van Oostveen RB, Romero-Palacios A, Whitlock R, Lee SF, Connolly S, Carignan A, Mazer CD, Loeb M, Mertz D. Prevention of Infections in Cardiac Surgery study (PICS): study protocol for a pragmatic cluster-randomized factorial crossover pilot trial. Trials. 2018 Dec 17;19(1):688. doi: 10.1186/s13063-018-3080-y. |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Vancomycin | Drug | administration as outlined |
|
Secondary outcome of eventual full trial
| 3 months post-surgery |
| Mortality | Secondary outcome of eventual full trial | 3 months post-surgery |
| Clostridium difficile infection | Secondary outcome of eventual full trial | 3 months post-surgery |
| Toronto |
| Ontario |
| M5B1W8 |
| Canada |
| Jewish Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| University of Sherbrook | Sherbrook | Quebec | J1H 5N4 | Canada |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |