Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery

Summary

The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and augmentation surgery is unknown. This is a comparative open label interventional trial comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate with short antibiotic treatment for up to 24 hours postoperatively. The primary study outcome is the postoperative surgical site infection in the standard versus the short treatment arms. Secondary outcomes are drug-related adverse events and Clostridium difficile infection.

Timeline

Start

2016-05

Primary completion

2018-05

Completion

2018-05

Publications

• Background Young PY, Khadaroo RG. Surgical site infections. Surg Clin North Am. 2014 Dec;94(6):1245-64. doi: 10.1016/j.suc.2014.08.008. Epub 2014 Oct 3.
• Background Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, Bolger A, Cabell CH, Takahashi M, Baltimore RS, Newburger JW, Strom BL, Tani LY, Gerber M, Bonow RO, Pallasch T, Shulman ST, Rowley AH, Burns JC, Ferrieri P, Gardner T, Goff D, Durack DT; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee; American Heart Association Council on Cardiovascular Disease in the Young; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Surgery and Anesthesia; Quality of Care and Outcomes Research Interdisciplinary Working Group. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2007 Oct 9;116(15):1736-54. doi: 10.1161/CIRCULATIONAHA.106.183095. Epub 2007 Apr 19.
• Background Anitua E, Aguirre JJ, Gorosabel A, Barrio P, Errazquin JM, Roman P, Pla R, Carrete J, de Petro J, Orive G. A multicentre placebo-controlled randomised clinical trial of antibiotic prophylaxis for placement of single dental implants. Eur J Oral Implantol. 2009 Winter;2(4):283-92.
• Background Mazzocchi A, Passi L, Moretti R. Retrospective analysis of 736 implants inserted without antibiotic therapy. J Oral Maxillofac Surg. 2007 Nov;65(11):2321-3. doi: 10.1016/j.joms.2007.06.620.
• Background Laskin DM, Dent CD, Morris HF, Ochi S, Olson JW. The influence of preoperative antibiotics on success of endosseous implants at 36 months. Ann Periodontol. 2000 Dec;5(1):166-74. doi: 10.1902/annals.2000.5.1.166.
• Background Choukroun J, Simonpieri A, Del Corso M, Mazor Z, Sammartino G, Dohan Ehrenfest DM. Controlling systematic perioperative anaerobic contamination during sinus-lift procedures by using metronidazole: an innovative approach. Implant Dent. 2008 Sep;17(3):257-70. doi: 10.1097/ID.0b013e318181349a.
• Background Testori T, Drago L, Wallace SS, Capelli M, Galli F, Zuffetti F, Parenti A, Deflorian M, Fumagalli L, Weinstein RL, Maiorana C, Di Stefano D, Valentini P, Gianni AB, Chiapasco M, Vinci R, Pignataro L, Mantovani M, Torretta S, Pipolo C, Felisati G, Padoan G, Castelnuovo P, Mattina R, Del Fabbro M. Prevention and treatment of postoperative infections after sinus elevation surgery: clinical consensus and recommendations. Int J Dent. 2012;2012:365809. doi: 10.1155/2012/365809. Epub 2012 Aug 9.
• Background Esposito M, Cannizzaro G, Bozzoli P, Checchi L, Ferri V, Landriani S, Leone M, Todisco M, Torchio C, Testori T, Galli F, Felice P. Effectiveness of prophylactic antibiotics at placement of dental implants: a pragmatic multicentre placebo-controlled randomised clinical trial. Eur J Oral Implantol. 2010 Summer;3(2):135-43.
• Background Esposito M, Grusovin MG, Loli V, Coulthard P, Worthington HV. Does antibiotic prophylaxis at implant placement decrease early implant failures? A Cochrane systematic review. Eur J Oral Implantol. 2010 Summer;3(2):101-10.
• Background Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.
• Background Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH; Society for Healthcare Epidemiology of America; Infectious Diseases Society of America. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. doi: 10.1086/651706.
• Background Lindeboom JA, van den Akker HP. A prospective placebo-controlled double-blind trial of antibiotic prophylaxis in intraoral bone grafting procedures: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Dec;96(6):669-72. doi: 10.1016/j.tripleo.2003.08.026.
• Background Herzberg R, Dolev E, Schwartz-Arad D. Implant marginal bone loss in maxillary sinus grafts. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):103-10.
• Background Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.

Drugs

Indications

No indication recorded.