Double blind randomized controlled trial for subjects undergoing surgery receiving surgical antimicrobial prophylaxis at tertiary hospital: the clinical pharmacist’s interventions
Main Article Content
Keywords
Adherence, Clinical pharmacist, Randomized clinical trial, Surgical antimicrobials prophylaxis (SAP), Surgical site infections (SSIs)
Abstract
Background: A surgical site infection (SSI) has significant clinical, humanistic and economic consequences. Surgical antimicrobials prophylaxis (SAP) is a reliable standard to prevent SSIs. Objective: The objective was to test that the clinical pharmacist’s interventions may facilitate the implementation of SAP protocol and subsequent reduction of SSIs. Methods: This was double blinded randomized controlled interventional hospital-based-study at Khartoum State-Sudan. A total of 226 subjects underwent general surgeries at four surgical units. Subjects were randomized to interventions and controls in a (1:1) ratio where patient, assessors and physician were blinded. The surgical team has received structured educational and behavioral SAP protocol mini courses by way of directed lecturers, workshops, seminars and awareness campaigns delivered by the clinical pharmacist. The clinical pharmacist provided SAP protocol to the interventions group. The outcome measure was the primary reduction in SSIs. Results: There were (51.8%, 117/226) females, (61/113 interventions versus 56/113 controls), and (48.2%, 109/226) males (52 interventions and 57 controls). The overall rate of SSIs was assessed during 14 days post-operatively and was documented in (35.4%, 80/226). The difference in adherence to locally developed SAP protocol regarding the recommended antimicrobial was significant (P <0.001) between the interventions group (78, 69%) and the controls group (59, 52.2%). The clinical pharmacist’s implementation of the SAP protocol revealed significant differences in SSIs with reduction in SSIs from 42.5% to 25.7% versus the controls group from 57.5% to 44.2% respectively, P = 0.001 between the interventions group and the controls group respectively. Conclusion: The clinical pharmacist’s interventions were very effective in sustainable adherence to SAP protocol and subsequent reduction in SSIs within the interventions group.
References
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21. Van Disseldorp J, Slingenberg EJ, Matute A, et al. Application of guidelines on preoperative antibiotic prophylaxis in Leon, Nicaragua. Neth J Med. 2006;64(11):411-416.
22. Van Kasteren ME, Kullberg BJ, de Boer AS, et al. Adherence to local hospital guidelines for surgical antimicrobial prophylaxis:a multicentre audit in Dutch hospitals. J Antimicrob Chemother. 2003;51(6):1389-1396. https://doi.org/10.1093/jac/dkg264
23. Lallemand S, Thouverez M, Bailly P, et al. Nonobservance of guidelines for surgical antimicrobial prophylaxis and surgicalsite infections. Pharm World Sci. 2002;24(3):95-99. https://doi.org/10.1023/a:1016122202439
24. Voit SB, Todd JK, Nelson B, et al. Electronic surveillance system for monitoring surgical antimicrobial prophylaxis. Pediatrics. 2005;116(6):1317-1322. https://doi.org/10.1542/peds.2004-1969
25. Gans I, Jain A, Sirisreetreerux N, et al. Current practice of antibiotic prophylaxis for surgical fixation of closed long bone fractures: A survey of 297 members of the Orthopaedic Trauma Association. Patient Saf Surg. 2017;11(1):2. https://doi.org/10.1186/s13037-016-0118-5
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28. Sami Galal, Clinical, Seif I Mahadi, et al. Antibiotics prophylaxis in elective surgery in Khartoum Teaching Hospital: current practice and surgical site infection. Sudan Med J. 2010;46(3).
29. Argaw N, Shumbash K, Asfaw A, et al. Assessment of surgical antimicrobial prophylaxis in Orthopaedics and Traumatology Surgical. BMC Research Notes. 2017;10(1):160. https://doi.org/10.1186/s13104-017-2475-2
30. López Pereira P, Díaz-Agero Pérez C, López Fresneña N, et al. Epidemiology of surgical site infection in a neurosurgery department. Br J Neurosurg. 2017;31(1):10-15. https://doi.org/10.1080/02688697.2016.1260687
31. Ahmed SO, Mahadi SI, Ahmed ME. Antibiotic prophylaxis in clean and clean-contaminated surgery and surgical site infection in Khartoum Teaching Hospital. Sudan Med J. 2015;50(3):24-32.
32. van Kasteren MEE, Mannien J, Kullberg B, et al. Quality improvement of surgical prophylaxis in Dutch hospitals: evaluation of a multi-site intervention by time series analysis. J Antimicrob Chemother. 2005;56(6):1094-1102. https://doi.org/10.1093/jac/dki374
33. Vessal G, Namazi S, Davarpanah M, et al. Evaluation of prophylactic antibiotic administration at the surgical ward of a major referral hospital, Islamic Republic of Iran. East Mediterr Health J. 2018;17(8):663-668.
34. Poeran J, Wasserman J, Zubizarreta N, et al. Characteristics of Antibiotic Prophylaxis and Risk of Surgical Site Infections in Open Colectomies. Dis Colon Rectum. 2016;59(8):733-742. https://doi.org/10.1097/DCR.0000000000000633
35. Weber W, Mujagic E, Zwahlen M, et al. Timing of surgical antimicrobial prophylaxis: a phase 3 randomized controlled trial.Lancet Infect Dis. 2017;17(6):605-614. https://doi.org/10.1016/S1473-3099(17)30176-7
36. Akalin S, Kutlu S, Cirak B, et al. Application of ATC/DDD methodology to evaluate perioperative antimicrobial prophylaxis. Int JClin Pharm. 2012;34(1):120-126. https://doi.org/10.1007/s11096-011-9601-3
37. Bratzler DW, Houck PM. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004;38(12):1706. https://doi.org/10.1086/421095
38. Bratzler DW, Dellinger EP, Olsen KM, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health-SystPharm. 2013;14(1):73-156. https://doi.org/10.1089/sur.2013.9999
39. Mehta Y, Gupta A, Todi S, et al. Guidelines for prevention of hospital acquired infections. Indian J Crit Care Med. 2014;18(3):149-163. https://doi.org/10.4103/0972-5229.128705
40. Guideline for isolation precautions: Preventing transmission of infectious agents in healthcare settings. 2014. Mar 10, Availablefrom: http://www.cdc.gov/hicpac/pdf/ isolation/Isolation2007.pdf. Accessed August 2018.
41. WHO. Report on the Burden of Endemic Health Care – Associated Infection Worldwide: A System Review of the Literature. 2011.[Last accessed on 2016 Oct 14]. Available from: http://www.apps.who.int/iris/bitstream/ 10665/80135/1/9789241501507_eng.pdf. Accessed October 2018.
42. Allegranzi B, Bagheri Nejad S, Combescure C, et al. Burden of endemic health-care-associated infection in developing countries:Systematic review and meta-analysis. Lancet. 2011;377(9761):228-241. https://doi.org/0.1016/S0140-6736(10)61458-4
43. Choudhuri AH, Chakravarty M, Uppal R. Epidemiology and characteristics of nosocomial infections in critically ill patientsin a tertiary care Intensive Care Unit of Northern India. Saudi J Anaesth. 2017;11(4):402-407. https://doi.org/10.4103/sja.sja_230_17
44. Alam M, Bastakoti B. Therapeutic Guidelines: Antibiotic. Version 15. Aust Prescr. 2015 Aug;38(4):137. https://doi.org/10.18773/austprescr.2015.049
2. Goede WJ, Lovely JK, Thompson RL, et al. Assessment of Prophylactic Antibiotic Use in Patients with Surgical Site Infections.Hosp Pharm. 2013;48(7):560-567. https://doi.org/10.1310/hpj4807-560
3. Singh R, Singla P, Chaudhary U. Surgical site infections: classification, risk factors, pathogenesis and preventive management:review article. Int J Pharma Research Health Sci. 2014;2(3):203-214.
4. Ameh EA1, Mshelbwala PM, Nasir AA, et al. Surgical site infection in children: prospective analysis of the burden and riskfactors in a sub-Saharan African setting. Surg Infect. 2009;10(2):105-109. 10.1089/sur.2007.082
5. Surgical Site Infection (SSI) Event: Center for Disease Control. 2010.http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf?agree=yes&next=Accept. Updated January 2015. Accessed May, 2018.
6. Branch-Elliman W, O’Brien W, Strymish J, et al. Association of Duration and Type of Surgical Prophylaxis with Antimicrobial-Associated Adverse Events. JAMA Surg. 2019;154(7):590-598. https://doi.org/10.1001/jamasurg.2019.0569
7. Bennett NJ, Bull AL, Dunt DR, et al. Surgical antibiotic prophylaxis in smaller hospitals. ANZ J Surg. 2006;76(8):676-678. https://doi.org/10.1111/j.1445-2197.2006.03826.x
8. Bratzler DW, Hunt DR. The surgical infection prevention and surgical care improvement projects: national initiatives to improve out comes for patients having surgery. Clin Infect Dis. 2006;43(3):322-330. https://doi.org/10.1086/505220
9. Pons-Busom M, Aguas-Compaired M, Delas J, et al. Compliance with local guidelines for antibiotic prophylaxis in surgery. Infect Control Hosp Epidemiol. 2004;25(4):308-312. https://doi.org/10.1086/502397
10. Alamrew K, Tadesse TA, Abiye AA, et al. Surgical Antimicrobial Prophylaxis and Incidence of Surgical Site Infections at Ethiopian Tertiary-Care Teaching Hospital. Infect Dis (Auckl). 2019 Nov 27;12:1178633719892267. https://doi.org/10.1177/1178633719892267
11. Lubega A, Joel B, Justina Lucy N. Incidence and etiology of surgical site infections among emergency postoperative patients in Mbarara regional referral hospital, South Western Uganda. Surg Res Pract. 2017;2017:6365172. https://doi.org/10.1177/1178633719892267
12. Gore S. Assessing clinical trials-restricted randomization. Br Med J. 1981;282(6282):2114-2117. https://doi.org/10.1136/bmj.282.6282.2114
13. Gore SM, Altman DG, Statistics in Practice. British Medical Association, London. Ingelfinger JA, Mosteller F, Thibodeau LA and Ware JH (1994). Biostatistics in Clinical Medicine (3rd ed). (1982). McGraw Hill, New York.
14. Alemkere G. Antibiotic usage in surgical prophylaxis: A prospective observational study in the surgical ward of Nekemte referral hospital. PLoS ONE. 2018; 13(9):e0203523. 10.1371/journal.pone.0203523
15. Liu J, Li N, Hao J, et al. Impact of the Antibiotic Stewardship Program on Prevention and Control of Surgical Site Infection during Peri-Operative Clean Surgery. Surg Infect. 2018;19(3):326-333. https://doi.org/10.1089/sur.2017.201
16. Weber W, Mujagic E, Zwahlen M, et al. Timing of surgical antimicrobial prophylaxis: a phase 3 randoized controlled trial. Lancet Infect Dis. 2017;17(6):605-614. https://doi.org/10.1016/S1473-3099(17)30176-7
17. Chandrananth J, Rabinovich A, Karahalios A, et al. Impact of adherence to local antibiotic prophylaxis guidelines on infection outcome after total hip or knee arthroplasty. J Hosp Infect. 2016;33(6):706. https://doi.org/10.4067/S0716-10182016000600017
18. Knox MC and Edye M. Adherence to Surgical Antibiotic Prophylaxis Guidelines in New South Wales, Australia: Identifying Deficiencies and Regression Analysis of Contributing Factors. Surg Infect. 2016; 17(2): 203-209. https://doi.org/10.1089/sur.2015.195
19. Al-Momany NH, Al-Bakri AG, Makahleh ZM, et al. Adherence to International Antimicrobial Prophylaxis Guidelines in Cardiac Surgery: A Jordanian Study Demonstrates Need for Quality Improvement. J Manag Care Pharm. 2009;15(3):262-271. https://doi.org/10.18553/jmcp.2009.15.3.262
20. Askarian M, Moravveji AR, Mirkhani H, et al. Adherence to American Society of Health-System Pharmacists surgical antibiotic prophylaxis guidelines in Iran. Infect Control Hosp Epidemiol. 2006;27(8):876-878. https://doi.org/10.1086/506405
21. Van Disseldorp J, Slingenberg EJ, Matute A, et al. Application of guidelines on preoperative antibiotic prophylaxis in Leon, Nicaragua. Neth J Med. 2006;64(11):411-416.
22. Van Kasteren ME, Kullberg BJ, de Boer AS, et al. Adherence to local hospital guidelines for surgical antimicrobial prophylaxis:a multicentre audit in Dutch hospitals. J Antimicrob Chemother. 2003;51(6):1389-1396. https://doi.org/10.1093/jac/dkg264
23. Lallemand S, Thouverez M, Bailly P, et al. Nonobservance of guidelines for surgical antimicrobial prophylaxis and surgicalsite infections. Pharm World Sci. 2002;24(3):95-99. https://doi.org/10.1023/a:1016122202439
24. Voit SB, Todd JK, Nelson B, et al. Electronic surveillance system for monitoring surgical antimicrobial prophylaxis. Pediatrics. 2005;116(6):1317-1322. https://doi.org/10.1542/peds.2004-1969
25. Gans I, Jain A, Sirisreetreerux N, et al. Current practice of antibiotic prophylaxis for surgical fixation of closed long bone fractures: A survey of 297 members of the Orthopaedic Trauma Association. Patient Saf Surg. 2017;11(1):2. https://doi.org/10.1186/s13037-016-0118-5
26. American College of Surgeons (ACS). Inguinal and Femoral Hernia Repair, last updated: Han.2018. available from: ttp://www.fda.gov. Accessed July 2018.
27. Musmar SM, Ba`ba H, Owais A. Adherence to guidelines of antibiotic prophylactic use in surgery: a prospective cohort study in North West Bank, Palestine. BMC Surg. 2014;14:69. https://doi.org/10.1186/1471-2482-14-69
28. Sami Galal, Clinical, Seif I Mahadi, et al. Antibiotics prophylaxis in elective surgery in Khartoum Teaching Hospital: current practice and surgical site infection. Sudan Med J. 2010;46(3).
29. Argaw N, Shumbash K, Asfaw A, et al. Assessment of surgical antimicrobial prophylaxis in Orthopaedics and Traumatology Surgical. BMC Research Notes. 2017;10(1):160. https://doi.org/10.1186/s13104-017-2475-2
30. López Pereira P, Díaz-Agero Pérez C, López Fresneña N, et al. Epidemiology of surgical site infection in a neurosurgery department. Br J Neurosurg. 2017;31(1):10-15. https://doi.org/10.1080/02688697.2016.1260687
31. Ahmed SO, Mahadi SI, Ahmed ME. Antibiotic prophylaxis in clean and clean-contaminated surgery and surgical site infection in Khartoum Teaching Hospital. Sudan Med J. 2015;50(3):24-32.
32. van Kasteren MEE, Mannien J, Kullberg B, et al. Quality improvement of surgical prophylaxis in Dutch hospitals: evaluation of a multi-site intervention by time series analysis. J Antimicrob Chemother. 2005;56(6):1094-1102. https://doi.org/10.1093/jac/dki374
33. Vessal G, Namazi S, Davarpanah M, et al. Evaluation of prophylactic antibiotic administration at the surgical ward of a major referral hospital, Islamic Republic of Iran. East Mediterr Health J. 2018;17(8):663-668.
34. Poeran J, Wasserman J, Zubizarreta N, et al. Characteristics of Antibiotic Prophylaxis and Risk of Surgical Site Infections in Open Colectomies. Dis Colon Rectum. 2016;59(8):733-742. https://doi.org/10.1097/DCR.0000000000000633
35. Weber W, Mujagic E, Zwahlen M, et al. Timing of surgical antimicrobial prophylaxis: a phase 3 randomized controlled trial.Lancet Infect Dis. 2017;17(6):605-614. https://doi.org/10.1016/S1473-3099(17)30176-7
36. Akalin S, Kutlu S, Cirak B, et al. Application of ATC/DDD methodology to evaluate perioperative antimicrobial prophylaxis. Int JClin Pharm. 2012;34(1):120-126. https://doi.org/10.1007/s11096-011-9601-3
37. Bratzler DW, Houck PM. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004;38(12):1706. https://doi.org/10.1086/421095
38. Bratzler DW, Dellinger EP, Olsen KM, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health-SystPharm. 2013;14(1):73-156. https://doi.org/10.1089/sur.2013.9999
39. Mehta Y, Gupta A, Todi S, et al. Guidelines for prevention of hospital acquired infections. Indian J Crit Care Med. 2014;18(3):149-163. https://doi.org/10.4103/0972-5229.128705
40. Guideline for isolation precautions: Preventing transmission of infectious agents in healthcare settings. 2014. Mar 10, Availablefrom: http://www.cdc.gov/hicpac/pdf/ isolation/Isolation2007.pdf. Accessed August 2018.
41. WHO. Report on the Burden of Endemic Health Care – Associated Infection Worldwide: A System Review of the Literature. 2011.[Last accessed on 2016 Oct 14]. Available from: http://www.apps.who.int/iris/bitstream/ 10665/80135/1/9789241501507_eng.pdf. Accessed October 2018.
42. Allegranzi B, Bagheri Nejad S, Combescure C, et al. Burden of endemic health-care-associated infection in developing countries:Systematic review and meta-analysis. Lancet. 2011;377(9761):228-241. https://doi.org/0.1016/S0140-6736(10)61458-4
43. Choudhuri AH, Chakravarty M, Uppal R. Epidemiology and characteristics of nosocomial infections in critically ill patientsin a tertiary care Intensive Care Unit of Northern India. Saudi J Anaesth. 2017;11(4):402-407. https://doi.org/10.4103/sja.sja_230_17
44. Alam M, Bastakoti B. Therapeutic Guidelines: Antibiotic. Version 15. Aust Prescr. 2015 Aug;38(4):137. https://doi.org/10.18773/austprescr.2015.049
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Double blind randomized controlled trial for subjects undergoing surgery receiving surgical antimicrobial prophylaxis at tertiary hospital: the clinical pharmacist’s interventions. Pharm Pract (Granada) [Internet]. 2022 Dec. 5 [cited 2024 Apr. 16];20(4):1-17. Available from: https://pharmacypractice.org/index.php/pp/article/view/2727
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Author Biography
Israa Y Al- Khidir
Clinical Pharmacist, University of Hail (UOH), Hail - King Saudia Arabia (KSA).