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Single-Dose Prophylactic Antibiotic Versus Extended Usage for Four Days in Clean-Contaminated Oncological Surgeries: a Randomized Clinical Trial

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Abstract

The optimal duration of prophylactic antimicrobial usage in clean-contaminated elective oncological surgeries is not clear. This single-center randomized trial evaluated the effectiveness of single-dose antimicrobial prophylaxis in clean-contaminated surgeries for the reduction of surgical site infection (SSI). Between April 2018 and January 2019, 315 patients undergoing major oncological clean-contaminated surgeries where the gastrointestinal or genital tract was opened under controlled conditions were randomized into 2 groups i.e., single dose versus extended dose groups. The single dose group received a 1.5 g dose of cefuroxime immediately before surgery while the extended group received the same dose of cefuroxime thrice daily for 4 days from the day of surgery till postoperative day 3. In addition, patients undergoing esophageal and colorectal surgeries received metronidazole. The overall SSI rate of the single dose group was not significantly different from that of the extended group (11.3% vs. 14.7%, respectively, p 0.40), with absolute difference of 3.4% and relative risk of 0.85 (95% C.I, 0.59 to 1.22). The rate of remote site infection was also not different between the two groups (14.4% vs 10.2%, p 0.31) with absolute difference of 4.2% and relative risk 1.19 (95% C.I, 0.89 to 1.59). In univariate analysis, parameters like nodal dissection, colorectal surgery, smoking, and hospital stay were significantly associated with SSI. In multivariate analysis, age, smoking, nodal dissection, and hospital stay retained significance. Single-dose antimicrobial prophylaxis is as effective as extended usage for 4 days in the prevention of postoperative SSI in patients undergoing clean-contaminated major oncological surgeries. Trial was registered with the clinical trial registry of India (CTRI/2018/06/014344).

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References

  1. Burke JP (2003) Infection control--a problem for patient safety. N Engl J Med 348:65–66

    Article  Google Scholar 

  2. Centers for Disease Control and Prevention (2001) National Nosocomial Infections Surveillance (NNIS) System report: data summary from January 1992–June 2001, issued August 2001. Am J Infect Control 29:404–421

    Article  Google Scholar 

  3. Mohri Y, Tonouchi H, Kobayashi M, Nakai K, Kusunoki M, Mie Surgical Infection Research Group (2007) Randomized clinical trial of single- versus multiple-dose antimicrobial prophylaxis in gastric cancer surgery. Br J Surg 94:683–688

    Article  CAS  Google Scholar 

  4. Nelson RL, Gladman E, Barbateskovic M (2014) Antimicrobial prophylaxis for colorectal surgery. Cochrane Database Syst Rev (5):CD001181

  5. Clarke-Pearson DL, Geller EJ (2013) Complications of hysterectomy. Obstet Gynecol 121:654–673

    Article  Google Scholar 

  6. Coppa GF, Eng K (1988) Factors involved in antibiotic selection in elective colon and rectal surgery. Surgery. 104:853–858

    CAS  PubMed  Google Scholar 

  7. Centers for Disease Control and Prevention. Procedure-associated Module. Surgical Site Infection (Internet). [Accessed 6th April 2019]. Available from https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

  8. Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Perl TM, Auwaerter PG et al (2013) Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect 14:73–156

    Article  Google Scholar 

  9. Juul PZ, Klaaborg KE, Kronborg O (1987) Single or multiple doses of metronidazole and ampicillin in elective colorectal surgery: a randomized trial. Dis Colon Rectum 30:526–528

    Article  CAS  Google Scholar 

  10. Göransson G, Nilsson-Ehle I, Olsson SA, Petersson BG, Bengmark S (1984) Single-versus multiple-dose doxycycline prophylaxis in elective colorectal surgery. Acta Chir Scand 150:245–249

    PubMed  Google Scholar 

  11. Berríos-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP, for the Healthcare Infection Control Practices Advisory Committee (2017) Centers for disease control and prevention guideline for the prevention of surgical site infection, 2017. JAMA Surg 152:784–791

    Article  Google Scholar 

  12. Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM (1988) CDC definitions for nosocomial infections, 1988 [published correction appears in am J infect control 1988 Aug;16(4):177]. Am J Infect Control 16(3):128–140

    Article  CAS  Google Scholar 

  13. National Nosocomial Infections Surveillance System (2004) National Nosocomial Infections Surveillance (NNIS) system report, data summary from January 1992 through June 2004, issued October 2004. Am J Infect Control 32:470–485

    Article  Google Scholar 

  14. Lilani SP, Jangale N, Chowdhary A, Daver GB (2005) Surgical site infection in clean and clean-contaminated cases. Indian J Med Microbiol 23:249

    CAS  PubMed  Google Scholar 

  15. Haga N, Ishida H, Ishiguro T, Kumamoto K, Ishibashi K, Tsuji Y, Miyazaki T (2012) A prospective randomized study to assess the optimal duration of intravenous antimicrobial prophylaxis in elective gastric cancer surgery. Int Surg 97:169–176

    Article  Google Scholar 

  16. Fujita S, Saito N, Yamada T, Takii Y, Kondo K, Ohue M, Ikeda E, Moriya Y (2007) Randomized, multicenter trial of antibiotic prophylaxis in elective colorectal surgery: single dose vs 3 doses of a second-generation cephalosporin without metronidazole and oral antibiotics. Arch Surg 142:657–661

    Article  CAS  Google Scholar 

  17. Imai E, Ueda M, Kanao K, Miyaki K, Kubota T, Kitajima M (2005) Surgical site infection surveillance after open gastrectomy and risk factors for surgical site infection. J Infect Chemother 11:141–145

    Article  Google Scholar 

  18. Tang R, Chen HH, Wang YL, Changchien CR, Chen J-S, Hsu K-C, Chiang JM, Wang JY (2001) Risk factors for surgical site infection after elective resection of the colon and rectum: a single-center prospective study of 2,809 consecutive patients. Ann Surg 234:181–189

    Article  CAS  Google Scholar 

  19. Ishibashi K, Kuwabara K, Ishiguro T, Ohsawa T, Okada N, Miyazaki T, Yokoyama M, Ishida H (2009) Short-term intravenous antimicrobial prophylaxis in combination with preoperative oral antibiotics on surgical site infection and methicillin-resistant Staphylococcus aureus infection in elective colon cancer surgery: results of a prospective randomized trial. Surg Today 39:1032–1039

    Article  CAS  Google Scholar 

  20. Suzuki T, Sadahiro S, Maeda Y, Tanaka A, Okada K, Kamijo A (2011) Optimal duration of prophylactic antibiotic administration for elective colon cancer surgery: a randomized, clinical trial. Surgery. 149:171–178

    Article  Google Scholar 

  21. Nelson RL, Suda KJ, Evans CT (2017) Antibiotic treatment for Clostridium difficile-associated diarrhoea in adults. Cochrane Database Syst Rev 3:CD004610

    Google Scholar 

  22. Imamura H, Kurokawa Y, Tsujinaka T, Inoue K, Kimura Y, Iijima S, Shimokawa T, Furukawa H (2012) Intraoperative versus extended antimicrobial prophylaxis after gastric cancer surgery: a phase 3, open-label, randomized controlled, non-inferiority trial. Lancet Infect Dis 12:381–387

    Article  CAS  Google Scholar 

  23. Takagane A, Mohri Y, Konishi T, Fukushima R, Noie T, Sueyoshi S, Omura K, Ono S, Kusunoki M, Mochizuki H, Sumiyama Y (2017) A randomized clinical trial of 24 versus 72 h antimicrobial prophylaxis in patients undergoing open total gastrectomy for gastric cancer. Br J Surg 104:e158–e164

    Article  CAS  Google Scholar 

  24. Han JH, Jeong O, Ryu SY, Jung MR, Park YK (2014) Efficacy of single-dose antimicrobial prophylaxis for preventing surgical site infection in radical gastrectomy for gastric carcinoma. J Gastric Cancer 14:156–163

    Article  Google Scholar 

  25. Ohashi M, Saka M, Katayama H, Okinaka K, Morita S, Fukagawa T, Katai H (2015) A prospective cohort study to evaluate the feasibility of intraoperative antimicrobial prophylaxis in open gastrectomy for gastric cancer. Surg Infect 16:833–839

    Article  Google Scholar 

  26. Zhang CD, Zeng YJ, Li Z, Chen J, Li H-W, Zhang J-K, Dai DQ (2013) Extended antimicrobial prophylaxis after gastric cancer surgery: a systematic review and meta-analysis. World J Gastroenterol 19:2104–2109

    Article  Google Scholar 

  27. Boodt PJ, Snijders WP, Janknegt R (1990) Single-dose prophylaxis in hysterectomies. An interim analysis. Pharm Weekbl Sci 12(6A):280–283

    Article  CAS  Google Scholar 

  28. American College of Obstetricians and Gynecologists (2009) Antibiotic prophylaxis for gynecologic procedures. ACOG practice bulletin no. 104. Obstet Gynecol 113:1180–1189

    Article  Google Scholar 

  29. Castoldi R, Ferrari G, Di Palo S, Orsenigo E, Bartucci F, DiCarlo V (1988) Prophylactic use of cefotaxime in biliary surgery. Comparison of single-dose versus multiple-dose schedule. Drugs 35(Suppl 2):151–153

    Article  Google Scholar 

  30. World health organization. Infection prevention and control. Global guidelines on prevention of surgical site infection. Appendix 25. Summary of the systematic review of surgical antibiotic prophylaxis prolongation (Internet). [Accessed 6th April 2019]. Available from https://www.who.int/gpsc/appendix25.pdf

  31. McDonald M, Grabsch E, Marshall C, Forbes A (1998) Single- versus multiple-dose antimicrobial prophylaxis for major surgery: a systematic review. Aust N Z J Surg 68:388–396

    Article  CAS  Google Scholar 

  32. Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG et al (2004) Wound infection after elective colorectal resection. Ann Surg 239:599–607

    Article  Google Scholar 

  33. Baum ML, Anish DS, Chalmers TC, Sacks HS, Smith H Jr, Fagerstrom RM (1981) A survey of clinical trials of antibiotic prophylaxis in colon surgery: evidence against further use of no-treatment controls. N Engl J Med 305:795–799

    Article  CAS  Google Scholar 

  34. Bullard KM, Trudel JL, Baxter NN, Rothenberger DA (2005) Primary perineal wound closure after preoperative radiotherapy and abdominoperineal resection has a high incidence of wound failure. Dis Colon Rectum 48:438–443

    Article  Google Scholar 

  35. Weber WP, Zwahlen M, Reck S, Misteli H, Rosenthal R (2009) Buser AS et al the association of preoperative anemia and perioperative allogeneic blood transfusion with the risk of surgical site infection. Transfusion. 49:1964–1970

    Article  Google Scholar 

  36. Mujagic E, Marti WR, Coslovsky M, Zeindler J, Staubli S, Marti R, Mechera R, Soysal SD, Gürke L, Weber WP (2018) The role of preoperative blood parameters to predict the risk of surgical site infection. Am J Surg 215:651–657

    Article  Google Scholar 

  37. Mahmoud NN, Turpin RS, Yang G, Saunders WB (2009) Impact of surgical site infections on length of stay and costs in selected colorectal procedures. Surg Infect 10:539–544

    Article  Google Scholar 

  38. Mujagic E, Marti WR, Coslovsky M, Soysal SD, Mechera R (2018) Strauss Mv et al. Associations of hospital length of stay with surgical site infections. World J Surg 42:3888–3896

    Article  Google Scholar 

  39. Kelly KJ, Greenblatt DY, Wan Y, Rettammel RJ, Winslow E, Cho CS, Weber SM (2011) Risk stratification for distal pancreatectomy utilizing ACS-NSQIP: preoperative factors predict morbidity and mortality. J Gastrointest Surg 15:250–261

    Article  Google Scholar 

  40. Gajdos C, Hawn MT, Campagna EJ, Henderson WG, Singh JA, Houston T (2012) Adverse effects of smoking on postoperative outcomes in cancer patients. Ann Surg Oncol 19:1430–1438

    Article  Google Scholar 

  41. Jørgensen MG, Toyserkani NM, Thomsen JB, Sørensen JA (2018) Surgical-site infection following lymph node excision indicates susceptibility for lymphedema: a retrospective cohort study of malignant melanoma patients. J Plast Reconstr Aesthet Surg 71:590–596

    Article  Google Scholar 

Download references

Acknowledgements

The authors like to acknowledge Dr. Hemant Nemade, Consultant Head and Neck Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, in helping with the statistical analysis of our data.

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Authors and Affiliations

  1. Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India

    Syed Nusrath, Sridhar Dasu, T. Subramanyeshwar Rao, K. V. V. N. Raju, Sujit C. Patnaik, R. Rajagopalan Iyer, Ajesh Raj Saksena & M. Ramanuja Rao

  2. Department of Anaesthesiology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India

    Abhijit Nair, Basanth Kumar Rayani, Vibhavari Milind Naik, Salman Saifuddin & Harini Narayanan

  3. Department of Microbiology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India

    Radha Rani Dandamudi

  4. Department of Clinical Research, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India

    Naresh Gupta

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  1. Syed Nusrath
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Nusrath, S., Nair, A., Dasu, S. et al. Single-Dose Prophylactic Antibiotic Versus Extended Usage for Four Days in Clean-Contaminated Oncological Surgeries: a Randomized Clinical Trial. Indian J Surg Oncol 11, 378–386 (2020). https://doi.org/10.1007/s13193-020-01163-x

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