Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial

Edgard Silva Garcia, Daniela Francescato Veiga, Joel Veiga-Filho, Isaías Vieira Cabral, Natália Lana Larcher Pinto, Neil Ferreira Novo, Miguel Sabino Neto, Lydia Masako Ferreira, Edgard Silva Garcia, Daniela Francescato Veiga, Joel Veiga-Filho, Isaías Vieira Cabral, Natália Lana Larcher Pinto, Neil Ferreira Novo, Miguel Sabino Neto, Lydia Masako Ferreira

Abstract

Background: The role of antibiotics in surgical procedures where the risk of surgical site infection (SSI) is low remains uncertain. There is, to date, no evidence to justify the routine use of antibiotics in postoperative reduction mammaplasty. The aim of this study is to evaluate the effect of postoperative antibiotic treatment on the occurrence of SSI after breast reduction surgery.

Methods: This is a double-blind randomized clinical trial with 124 breast hypertrophy patients allocated to two treatment groups: antibiotic (n = 62) and placebo (n = 62). All patients will undergo reduction mammoplasty, performed by the same surgical team. The surgeons will raise the nipple-areola complex by the superomedial pedicle technique. The patients will receive antibiotics intravenously during anesthetic induction and every 6 hours thereafter during their 24-hour hospital stay. During discharge from the hospital, each patient will receive a numbered package containing either cephalexin or placebo capsules and will be directed to take one capsule every 6 hours for 7 days. Neither the surgery team nor the patients will know the contents of the capsules. Patients will be monitored for the occurrence of SSI once weekly during the first 30 days following hospital discharge by a single surgeon who is blinded to their treatment group. SSI will be evaluated based on the definition adopted by the Centers for Disease Control and Prevention.

Discussion: Due to the variety of risk factors for SSI and limited case studies, conclusions regarding the effect of antibiotics on the occurrence of SSIs following reduction mammaplasty are potentially biased. In recent studies, perioperative antibiotic prophylaxis was effective in preventing infection and is therefore recommended in clinical practice. However, antibiotic use in the postoperative period still remains controversial.

Trial registration: Clinicaltrials.gov Identifier: NCT02569866 . Registered on 4 October 2015.

Keywords: Mammaplasty; Plastic surgery; Prophylaxis; Wound infection.

References

    1. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp. 1992;13:606–8. doi: 10.1017/S0195941700015241.
    1. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection. Infect Control Hosp Epidemiol. 1999;20:247–78. doi: 10.1086/501620.
    1. Junker T, Mujagic E, Hoffmann H, Rosenthal R, Misteli H, Zwahlen M, Oertli D, Tschudin-Sutter S, Widmer A, Marti W, Weber W. Prevention and control of surgical site infections: review of the Basel Cohort Study. Swiss Med Wkly. 2012;142:w13616.
    1. Humphreys H. Preventing surgical site infection. Where now? J Hosp Infect. 2009;73:316–22. doi: 10.1016/j.jhin.2009.03.028.
    1. Landes G, Harris PG, Lemaine V, Perreault I, Sampalis JS, Brutus JP, Lessard L, Dionyssopoulos A, Nikolis A. Prevention of surgical site infection and appropriateness of antibiotic prescribing habits in plastic surgery. J Plast Reconstr Aesthet Surg. 2008;61:1347–56. doi: 10.1016/j.bjps.2008.02.008.
    1. Andenaes K, Amland PF, Lingaas E, Abyholm F, Samdal F, Giercksky KE. A prospective, randomized surveillance study of postoperative wound infections after plastic surgery: a study of incidence and surveillance methods. Plast Reconstr Surg. 1995;96:948–56. doi: 10.1097/00006534-199509001-00028.
    1. Baran GN, Sensoz O, Ulusoy G. Prophylactic antibiotics in plastic and reconstructive surgery. Plast Reconstr Surg. 1998;103:1561–6. doi: 10.1097/00006534-199905000-00002.
    1. Perrotti JA, Castor SA, Perez PC, Zins JE. Antibiotic use in aesthetic surgery: a national survey and literature review. Plast Reconstr Surg. 2002;109:1685–93. doi: 10.1097/00006534-200204150-00033.
    1. Kompatscher P, von Planta A, Spicher I, Seifert B, Vetter S, Minder J, Beer GM. Comparison of the incidence and predicted risk of early surgical site infections after breast reduction. Aesthetic Plast Surg. 2003;27:308–14. doi: 10.1007/s00266-003-3010-5.
    1. Kerrigan CL, Slezak SS. Evidence-based medicine: reduction mammaplasty. Plast Reconstr Surg. 2013;132:1670–83.
    1. Rohrich RJ, Rios JL. The role of prophylactic antibiotics in plastic surgery: whom are we treating? Plast Reconstr Surg. 2003;112:617–8. doi: 10.1097/01.PRS.0000067440.39522.17.
    1. Krizek TJ, Koss N, Robson MC. The current use of prophylactic antibiotics in plastic and reconstructive surgery. Plast Reconstr Surg. 1975;55:21–32. doi: 10.1097/00006534-197501000-00004.
    1. Nichols RL. Preventing surgical site infections: a surgeon’s perspective. Emerg Infect Dis. 2001;7:220–4. doi: 10.3201/eid0702.010214.
    1. Throckmorton AD, Boughey JC, Boostrom SY, Holifield AC, Stobbs MM, Hoskin T, Baddour LM, Degnim AC. Postoperative prophylactic antibiotics and surgical site infection rates in breast surgery patients. Ann Surg Oncol. 2009;16:2464–9. doi: 10.1245/s10434-009-0542-1.
    1. Mirzabeigi MN, Mericli AF, Ortlip T, Tuma GA, Copit SE, Fox JW, IV, Moore JH., Jr Evaluating the role of postoperative prophylactic antibiotics in primary and secondary breast augmentation: a retrospective review. Aesthet Surg J. 2012;32:61–8. doi: 10.1177/1090820X11430830.
    1. Sajid MS, Hutson K, Akhter N, Kalra L, Rapisarda IF, Bonomi R. An updated meta-analysis on the effectiveness of preoperative prophylactic antibiotics in patients undergoing breast surgical procedures. Breast J. 2012;18(4):312–7. doi: 10.1111/j.1524-4741.2012.01248.x.
    1. Xue DQ, Qian C, Yang L, Wang XF. Risk factors for surgical site infections after breast surgery: a systematic review and meta-analysis. EJSO. 2012;38:375–81. doi: 10.1016/j.ejso.2012.02.179.
    1. Shortt R, Cooper MJ, MPhil FF, Bain J. Meta-analysis of antibiotic prophylaxis in breast reduction surgery. Plast Surg. 2014;22(2):91–4.
    1. Degnim AC, Throckmorton AD, Boostrom SY, Boughey JC, Holifield A, Baddour LM, Hoskin TL. Surgical site infection after breast surgery: impact of 2010 CDC reporting guidelines. Ann Surg Oncol. 2012;19(13):4099–103. doi: 10.1245/s10434-012-2448-6.
    1. Hedrick TL, Smith PW, Gazoni LM, Sawyer RG. The appropriate use of antibiotics in surgery: a review of surgical infections. Curr Probl Surg. 2007;44:635–75. doi: 10.1067/j.cpsurg.2007.06.006.
    1. Peled IJ, Dvir G, Berger J, Ramon I, Ullmann Y, Nachlieli T. Prophylactic antibiotics in aesthetic and reconstructive surgery. Aesthetic Plast Surg. 2000;24:299–302. doi: 10.1007/s002660010050.
    1. Ng D, Trivedi PM, Sharma AK, Banerjee D. Current use of antibiotic prophylaxis in breast surgery: a nationwide survey. Breast. 2007;16:68–72. doi: 10.1016/j.breast.2006.06.004.
    1. Ahmadi AH, Cohen BE, Shayani P. A prospective study of antibiotic efficacy in preventing infection in reduction mammaplasty. Plast Reconstr Surg. 2005;116:126–31. doi: 10.1097/01.PRS.0000169719.10060.32.
    1. Serletti JM, Davenport MS, Herrera HR, Caldwell EH. Efficacy of prophylactic antibiotics in reduction mammoplasty. Ann Plast Surg. 1994;33:476–80. doi: 10.1097/00000637-199411000-00003.
    1. Hall JC, Willsher PC, Hall JL. Randomized clinical trial of single-dose antibiotic prophylaxis for non-reconstructive breast surgery. Br J Surg. 2006;93:1342–6. doi: 10.1002/bjs.5505.
    1. Gupta R, Sinnett D, Carpenter R, Preece PE, Royle GT. Antibiotic prophylaxis for post- operative wound infection in clean elective breast surgery. Eur J Surg Oncol. 2000;26:363–6. doi: 10.1053/ejso.1999.0899.
    1. Okoro SA, Barone C, Bohnenblust M, Wang HT. Breast reduction trend among plastic surgeons: a national survey. Plast Reconstr Surg. 2008;122:1312–20. doi: 10.1097/PRS.0b013e3181881dd7.
    1. Iwuagwu OC, Platt AJ, Drew PJ. Breast reduction in the UK and Ireland – current trends. Ann R Coll Surg Engl. 2006;88:585–8. doi: 10.1308/003588406X130598.
    1. Platt R, Zucker JR, Zaleznik DF, Hopkins CC, Dellinger EP, Karchmer AW, Bryan CS, Burke JF, Wikler MA, Marino SK. Perioperative antibiotic prophylaxis and wound infection following breast surgery. J Antimicrob Chemother. 1993;31(suppl B):43–8. doi: 10.1093/jac/31.suppl_B.43.
    1. White RR, 4th, Pitzer KD, Fader RC, Rajab MH, Song J. Pharmacokinetics of topical and intravenous cefazolin in patients with clean surgical wounds. Plast Reconstr Surg. 2008;122:1773–9. doi: 10.1097/PRS.0b013e31818d5899.
    1. O’Grady KF, Thoma A, Dal CA. A comparison of complication rates in large and small inferior pedicle reduction mammaplasty. Plast Reconstr Surg. 2005;115:736–42. doi: 10.1097/01.PRS.0000152428.43300.19.
    1. Veiga-Filho J, Veiga DF, Sabino-Neto M, Amorim MC, Novo NF, Ferreira LM. The role of antibiotics in reduction mammaplasty. Ann Plast Surg. 2010;65(2):144–6. doi: 10.1097/SAP.0b013e3181c47d88.
    1. Freire M, Neto MS, Garcia EB, Quaresma MR, Ferreira LM. Quality of life after reduction mammaplasty. Scand J Plast Reconstr Hand Surg. 2004;38:1–5. doi: 10.1080/02844310410034295.
    1. Freire M, Neto MS, Garcia EB, Quaresma MR, Ferreira LM. Functional capacity and postural pain outcomes after reduction mammaplasty. Plast Reconstr Surg. 2007;119:1149–58. doi: 10.1097/01.prs.0000254358.55104.9f.
    1. Stevens WG, Gear AJ, Stoker DA, Hirsch EM, Cohen R, Spring M, Vath SD, Schantz SA, Heck RT. Outpatient reduction mammaplasty: an eleven-year experience. Aesthetic Surg J. 2008;28:171–9. doi: 10.1016/j.asj.2008.01.001.
    1. Setälä L, Papp A, Joukainen S, Martikainen R, Berg L, Mustonen P, Härmä M. Obesity and complications in breast reduction surgery: are restrictions justified? J Plast Reconstr Aesthetic Surg. 2009;62:195–9. doi: 10.1016/j.bjps.2007.10.043.
    1. Olsen MA, Chu-Ongsakul S, Brandt KE, Dietz JR, Mayfield J, Fraser VJ. Hospital-associated costs due to surgical site infection after breast surgery. Arch Surg. 2008;143:53–60. doi: 10.1001/archsurg.2007.11.
    1. Sacchini V, Luini A, Tana S, Lozza L, Galimberti V, Merson M, Agresti R, Veronesi P, Greco M. Quantitative and qualitative cosmetic evaluation after conservative treatment for breast cancer. Eur J Cancer. 1991;27(11):395–400. doi: 10.1016/0277-5379(91)90019-A.
    1. Franco T. Cirurgia estética da mama. In: Franco T, Franco D, Gonçalves LFF, editors. Princípios de cirurgia plástica. São Paulo: Atheneu; 2002. pp. 671–97.
    1. Orlando JC, Guthrie RH. The superomedial dermal pedicle for nipple transposition. Br J Plast Surg. 1975;28(1):42–5. doi: 10.1016/S0007-1226(75)90149-6.
    1. Veiga DF, Damasceno CA, Veiga-Filho J, Figueiras RG, Vieira RB, Garcia ES, Silva VV, Novo NF, Ferreira LM. Randomized controlled trial of the effectiveness of chlorhexidine showers before elective plastic surgical procedures. Infect Control Hosp Edpidemiol. 2009;30(1):77–9. doi: 10.1086/592980.
    1. Veiga DF, Damasceno CA, Veiga-Filho J, Figueiras RG, Vieira RB, Florenzano FH, Juliano Y, Ferreira LM. Povidone iodine versus chlorhexidine in skin antisepsis before elective plastic surgery procedures: a randomized controlled trial. Plast Reconstr Surg. 2008;122(5):170e–1. doi: 10.1097/PRS.0b013e318186cd7f.
    1. Sørensen LT, Hørby J, Friis E, Pilsgaard B, Jørgensen T. Smoking as a risk factor for wound healing and infection in breast cancer surgery. Eur J Surg Oncol. 2002;28(8):815–20. doi: 10.1053/ejso.2002.1308.
    1. Gao YX, Xu L, Ye JM, Wang DM, Zhao JX, Zhang LB, Duan XN, Liu YH. Analysis of risk factors of surgical site infections in breast cancer. Chin Med J. 2010;123(5):559–62.
    1. Vilar-Compte D, Rosales S, Hernandez-Mello N, Maafs E, Volkow P. Surveillance, control, and prevention of surgical site infections in breast cancer surgery: a 5-year experience. Am J Infect Control. 2009;37(8):674–9. doi: 10.1016/j.ajic.2009.02.010.
    1. Vilar-Compte D, Jacquemin B, Robles-Vidal C, Volkow P. Surgical site infections in breast surgery: case-control study. World J Surg. 2004;28(3):242–6. doi: 10.1007/s00268-003-7193-3.
    1. Vilar-Compte D, Roldán-Marín R, Robles-Vidal C, Volkow P. Surgical site infection (SSI) rates among patients who underwent mastectomy after the introduction of SSI prevention policies. Infect Control Hosp Epidemiol. 2006;27(8):829–34. doi: 10.1086/506395.
    1. Penel N, Yazdanpanah Y, Chauvet MP, Clisant S, Giard S, Neu JC, Lefebvre D, Fournier C, Bonneterre J. Prevention of surgical site infection after breast cancer surgery by targeted prophylaxis antibiotic in patients at high risk of surgical site infection. J Surg Oncol. 2007;96(2):124–9. doi: 10.1002/jso.20796.
    1. Felippe WA, Werneck GL, Santoro-Lopes G. Surgical site infection among women discharged with a drain in situ after breast cancer surgery. World J Surg. 2007;31(12):2293–9. doi: 10.1007/s00268-007-9248-3.
    1. Amland PF, Andenaes K, Samdal F, Lingaas E, Sandsmark M, Abyholm F, Giercksky KE. A prospective, double-blind, placebo-controlled trial of a single dose of azithromycin on postoperative wound infections in plastic surgery. Plast Reconstr Surg. 1995;96(6):1378–83. doi: 10.1097/00006534-199511000-00022.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅