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Cefoxitin Versus Piperacillin– Tazobactam As Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy: Protocol for a Randomised Controlled Trial

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Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-048398 on 4 March 2021. Downloaded from Cefoxitin versus piperacillin– tazobactam as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy: protocol for a randomised controlled trial Nicole M Nevarez ,1 Brian C Brajcich,2 Jason Liu,2,3 Ryan Ellis,2 Clifford Y Ko,2 Henry A Pitt,4 Michael I D'Angelica,5 Adam C Yopp1 To cite: Nevarez NM, ABSTRACT Strengths and limitations of this study Brajcich BC, Liu J, et al. Introduction Although antibiotic prophylaxis is Cefoxitin versus piperacillin– established in reducing postoperative surgical site tazobactam as surgical ► A major strength of this study is the multi- infections (SSIs), the optimal antibiotic for prophylaxis in antibiotic prophylaxis institutional, double- arm, randomised controlled in patients undergoing pancreatoduodenectomy (PD) remains unclear. The study trial design. objective is to evaluate if administration of piperacillin– pancreatoduodenectomy: ► A limitation of this study is that all perioperative care protocol for a randomised tazobactam as antibiotic prophylaxis results in decreased is at the discretion of the operating surgeon and is controlled trial. BMJ Open 30- day SSI rate compared with cefoxitin in patients not standardised. 2021;11:e048398. doi:10.1136/ undergoing elective PD. ► All data will be collected through the American bmjopen-2020-048398 Methods and analysis This study will be a multi- College of Surgeons National Surgical Quality ► Prepublication history for institution, double- arm, non- blinded randomised controlled Improvement Program, which is a strength for its this paper is available online. superiority trial. Adults ≥18 years consented to undergo PD ease of use but a limitation due to the variety of data To view these files, please visit for all indications who present to institutions participating included. the journal online (http:// dx. doi. in the National Surgical Quality Improvement Program org/ 10. 1136/ bmjopen- 2020- Hepato- Pancreato- Biliary (NSQIP HPB) Collaborative 048398). will be included. Data collection will use the NSQIP HPB Trial registration number NCT03269994. http://bmjopen.bmj.com/ Received 27 December 2020 Collaborative Surgical Clinical Reviewers. Patients will be randomised to either 1–2 g intravenous cefoxitin or Revised 02 February 2021 INTRODUCTION Accepted 04 February 2021 3.375–4.5 g intravenous piperacillin–tazobactam within 60 min of surgical incision. The primary outcome will be Surgical site infections (SSIs) remain the 30- day postoperative SSI rate following PD. Secondary most common and costly of all hospital- outcomes will include 30- day postoperative mortality; acquired infections (HAIs), accounting for 1 specific postoperative complication rate; and unplanned nearly 20% of all HAIs. SSIs are associated reoperation, length of stay, and hospital readmission. with increased length of stay and a twofold to on September 26, 2021 by guest. Protected copyright. A subset of patients will have bacterial isolates and 11- fold increase in mortality. Despite rates of sensitivities of intraoperative bile cultures and SSIs. SSI in other complex abdominal operations Postoperative SSIs and secondary outcomes will be decreasing, the SSI rate after pancreatoduo- analysed using logistic regression models with the primary denectomy (PD) has remained unchanged, predictor as the randomised treatment group. Additional ranging from 11% to 48%.2 An analysis of adjustment will be made for preoperative biliary stent data from the approximately 70 institutions presence. Additionally, bacterial cultures and isolates within the Hepato- Pancreato- Biliary (HPB) will be summarised by presence of bacterial species and © Author(s) (or their Collaborative of the American College of employer(s)) 2021. Re- use antibiotic sensitivities. Surgeons National Surgical Quality Improve- Ethics and dissemination This study is approved permitted under CC BY-NC. No ment Program (ACS NSQIP) detailing 3592 commercial re- use. See rights by the Institutional Review Board at Memorial Sloan and permissions. Published by Kettering Cancer Center. This trial will evaluate the effect PDs in 2015 revealed the rate of postopera- BMJ. of piperacillin–tazobactam compared with cefoxitin as tive combined superficial incisional, deep For numbered affiliations see antibiotic prophylaxis on the hazard of postoperative SSIs. incisional and organ/space SSIs to be 21.7% end of article. The results will be disseminated regardless of the effect (n=778). This SSI rate was nearly threefold the of the intervention on study outcomes. The manuscript rate after colon resections, which was 8.9% in Correspondence to 3 Dr Adam C Yopp; describing the effect of the intervention will be submitted ACS NSQIP hospitals in 2015. Factors asso- adam. yopp@ utsouthwestern. to a peer- reviewed journal when data collection and ciated with the high rate of SSIs in patients edu analyses are complete. undergoing PD include preoperative biliary Nevarez NM, et al. BMJ Open 2021;11:e048398. doi:10.1136/bmjopen-2020-048398 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-048398 on 4 March 2021. Downloaded from stenting, malnutrition, receipt of neoadjuvant therapy piperacillin–tazobactam as antibiotic prophylaxis will and prolonged operative duration among others.4–7 reduce rates of SSI after PD compared with cefoxitin. In 2003, the Centers for Medicare and Medicaid Services initiated a programme to reduce preventable Study setting 8–10 surgical complications including SSIs. This effort This trial will be carried out among the 80 institutions resulted in the creation of the Surgical Care Improvement in the USA participating in both the ACS NSQIP HPB 11–13 Project (SCIP) measures. The three SCIP measures Collaborative and ACS NSQIP Procedure Targeted with regard to antibiotics and SSI prevention include (1) Pancreatectomy Program. ACS NSQIP is a nationally vali- administration of antibiotics within 1 hour of incision dated, risk- adjusted, outcome- based effort to measure time, (2) selection of appropriate antibiotic therapy and and improve surgical care. The programme employs a (3) discontinuation of antibiotics within 24 hours after prospective data registry to quantify 30- day, risk- adjusted surgery end time (or 48 hours for cardiac procedures). surgical outcomes, which provide a standardised compar- The current SCIP guidelines recommend a one-time dose ison of outcomes among all participating hospitals.24 In of cefotetan, cefoxitin, ampicillin/sulbactam, or ertap- an internal analysis, 2210 PDs were conducted in 2015 enem or cefazolin or cefuroxime plus metronidazole with specifically at these institutions participating in the ACS no evidence of Β-lactam allergy as antimicrobial prophy- NSQIP Procedure Targeted Pancreatectomy Program.3 laxis in PD; alternative agents in patients with a B- lactam allergy include clindamycin or vancomycin plus amino- Patient population and eligibility criteria glycoside or aztreonam or fluoroquinolone.13 The study population will consist of all patients ≥18 years Although administration of a first-generation or of age at the ACS NSQIP HPB Collaborative institutions second- generation cephalosporin in patients under- undergoing elective PD for all indications (cancer and going PD remains the most common antibiotic regimen non- cancer). Exclusion criteria include patients under- for surgical prophylaxis, observational studies have going a minimally invasive (laparoscopic or robotic) PD; suggested that these regimens may provide inadequate known and documented allergies to any of the penicil- coverage for Enterococcus spp, Escherichia coli, and Kleb- 14–20 lins, cephalosporins or β-lactamase inhibitors; patients siella spp. These organisms are the most common highly unlikely to undergo PD according to the surgeon’s isolates from SSIs following PD, especially in patients 14–20 judgement, such as conditions amenable to pancreas what have had preoperative biliary stenting. Two enucleation or ampullectomy; patients with long-term retrospective studies compared the rate of SSI following glucocorticosteroid use; patients unable to provide PD when antimicrobial surgical prophylaxis was changed from the SCIP recommended cefoxitin (62%), cefazolin informed consent; patients with renal insufficiency or failure with creatinine clearance ≤40 mL/min or receiving and metronidazole (15%) and clindamycin (8%) to a http://bmjopen.bmj.com/ piperacillin–tazobactam regimen. In both studies, the haemodialysis or peritoneal dialysis; pregnant or nursing rate of SSI decreased twofold to fivefold, following use (lactating) women; patients with a known bacterial infec- of piperacillin–tazobactam for antibiotic prophylaxis.21 22 tion present at the time of surgery or who received anti- Currently there is one prospective, non- randomised study microbial therapy within 7 days prior to surgery. using piperacillin–tazobactam for antibiotic prophylaxis; this study which showed that patients had a higher rate of Recruitment HAI (43% vs 33%; p=0.004), superficial SSI (11% vs 2%; This study will be open to all patients seen at the partic- 23 ipating ACS NSQIP HPB Collaborative institutions who p<0.001) and pneumonia (16% vs 9%; p=0.006). on September 26, 2021 by guest. Protected copyright. meet the eligibility criteria described above. Further- Objective more, to be a participating institution, the hospital must The objective of this study is to determine if administra- be part
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