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To analyse the efficacy of different preoperative prophylactic antimicrobial regimens for perioperative infection prevention in patients undergoing hepatobiliary surgery in a high antimicrobial resistance setting.
Given the high incidence of postoperative surgical site infections (SSI) potentially attributable to bacterial antimicrobial resistance, the use of beta-lactam/beta-lactamase inhibitor combinations for prophylaxis may reduce SSI rates following hepatobiliary surgery in the current era of high antimicrobial resistance. To test this hypothesis, we propose a prospective pragmatic trial comparing piperacillin-tazobactam with the standard prophylactic regimen of cefuroxime for perioperative infection prevention in patients undergoing hepatobiliary surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery. |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin-tazobactam | Drug | Participants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery. Participants in the cotrol group will receive cefuroxime for prophylactic antibiotic. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with surgical site infection within 30 days after surgery | The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual. | 30 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | 30 days after the surgery | |
| Number of Participants with Sepsis within 30 days after surgery | Sepsis was defined according to criteria of the third international consensus of sepsis (doi: 10.1001/jama.2016.0287). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dayu Chen, Pharmacist in Charge, PharmD | Contact | +86-025-83106666-60924 | cdy_pharmacy@njglyy.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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This is a single-centre, prospective, open-label, randomised pragmatic trial evaluating the efficacy of piperacillin-tazobactam as a perioperative prophylactic antimicrobial agent for the prevention of surgical site infection following hepatobiliary surgery in a high antimicrobial resistance setting. Participants in the intervention arm receive piperacillin-tazobactam for perioperative prophylaxis, whereas those in the control arm receive cefuroxime.
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| 30 days after the surgery |
| Number of Participants with Postoperative bile leak or pancreas fisula | Postoperative bile leak and pancreas fisula was assessed by the treating surgeons. | 30 days after surgery |
| Postoperative hospital stay | Length of postoperative hospital stay from date of surgery until the date of first documented date of discharge from any cause, whichever came first, assessed up to 90 days. |
| Number of participants with infections other than surgical site infection | Infection was assessed by the treating surgeons. | Other infections occurred within 30 days after surgery. |
| Number of Participants with unplanned readmission and secondary surgery | Unplanned readmission and secondary surgery within 30 days after surgery. |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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