Standard abdominal wound edge protection with surgical dressings vs coverage with a sterile circular polyethylene drape for prevention of surgical site infections (BaFO): study protocol for a randomized controlled trial

Trials

Helmut Friess²  Jörg Kleeff²  Christoph Schuhmacher²  Tibor Schuster¹  Carsten Jäger³  Carolin Reiser-Erkan³  Mert Erkan³  Christoph W Michalski³  André L Mihaljevic² 

[1] Institute for Medical Statistics and Epidemiology, Klinikum Rechts der Isar, Technische Universtität München, Ismaninger Str. 22, Munich, 81675, Germany;CHIR-Net. Munich, Munich, Germany;Department of Surgery, Klinikum Rechts der Isar, Technische Universität München, Ismaningerstrasse 22, Munich, 81675, Germany

关键词: Wound infection;    Wound edge protector;    Surgical site infection;    Randomized trial;    Abdominal surgery;    Abdominal dressing;   

Others  :  1095592
DOI  :  10.1186/1745-6215-13-57

 received in 2011-09-14, accepted in 2012-03-09,  发布年份 2012

【 摘 要 】

Background

Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality and remain one of the most frequent surgical complications. Approximately 14% to 30% of all patients undergoing elective open abdominal surgery are affected and methods to reduce surgical site infection rates warrant further investigation and evaluation in randomized controlled trials.

Methods/design

To investigate whether the application of a circular plastic wound protector reduces the rate of surgical site infections in general and visceral surgical patients that undergo midline or transverse laparotomy by 50%. BaFO is a randomized, controlled, patient-blinded and observer-blinded multicenter clinical trial with two parallel surgical groups. The primary outcome measure will be the rate of surgical site infections within 45 days postoperative assessed according to the definition of the Center for Disease Control. Statistical analysis of the primary endpoint will be based on the intention-to-treat population. The global level of significance is set at 5% (2 sided) and sample size (n = 258 per group) is determined to assure a power of 80% with a planned interim analysis for the primary endpoint after the inclusion of 340 patients.

Discussion

The BaFO trial will explore if the rate of surgical site infections can be reduced by a single, simple, inexpensive intervention in patients undergoing open elective abdominal surgery. Its pragmatic design guarantees high external validity and clinical relevance.

Trial registration

http://www.clinicaltrials.gov webcite NCT01181206. Date of registration: 11 August 2010; date of first patient randomized: 8 September 2010

【 授权许可】

   
2012 Mihaljevic et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Hawn MT, Itani KM, Gray SH, Vick CC, Henderson W, Houston TK: Association of timely administration of prophylactic antibiotics for major surgical procedures and surgical site infection. J Am Coll Surg 2008, 206:814-819.
• [2]Belda FJ, Aguilera L, de la García-Asunción J, Alberti J, Vicente R, Ferrándiz L, Rodríguez R, Company R, Sessler DI, Aguilar G, Botello SG, Ortí R: Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA 2005, 294:2035-2042.
• [3]Kurz A: Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol 2008, 22:39-62.
• [4]Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ: The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol 1999, 20:725-730.
• [5]Gastmeier P, Brunkhorst F, Schrappe M, Kern W, Geffers C: How many nosocomial infections are avoidable? [in German]. Dtsch Med Wochenschr 2010, 135:91-93.
• [6]Geffers C, Rüden H: Gesundheitberichterstattung des Bundes, Nosokomiale Infektionen. [http://www.gbe-bund.de/gbe10/ergebnisse.prc_tab?fid=7845&suchstring=Heft_8&query_id=&sprache=D&fund_typ=TXT&methode=2&vt=1&verwandte=1&page_ret=0&seite=&p_lfd_nr=1&p_news=&p_sprachkz=D&p_uid=gast&p_aid=71600403&hlp_nr=3&p_janein=J webcite]
• [7]Geffers C, Sohr D, Gastmeier P: Mortality attributable to hospital-acquired infections among surgical patients. Infect Control Hosp Epidemiol 2008, 29:1167-1170.
• [8]ECDC: Annual epidemiological report on communicable diseases in Europe. [http://ecdc.europe.eu/health_topics/HCAI webcite]
• [9]Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR: Guideline for prevention of surgical site infection, Centres for Disease Control and Prevention (CDC) hospital infection control practices advisory committee. Am J Infect Control 1999, 1999(27):97-132.
• [10]Page CP, Bohnen JM, Fletcher JR, McManus AT, Solomkin JS, Wittmann DH: Antimicrobial prophylaxis for surgical wounds. Guidelines for clinical care. Arch Surg 1993, 128:79-88.
• [11]Bratzler DW, Houck PM: Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Am J Surg 2005, 189:395-404.
• [12]Dellinger EP, Gross PA, Barrett TL, Krause PJ, Martone WJ, McGowan JE, Sweet RL, Wenzel RP: Quality standard for antimicrobial prophylaxis in surgical procedures. The Infectious Diseases Society of America. Infect Control Hosp Epidemiol 1994, 15:182-188.
• [13]Napolitano LM: Decolonization of the skin of the patient and surgeon. Surg Infect 2006, 7(Suppl 3):3-15.
• [14]Itani KMF, Wilson SE, Awad SS, Jensen EH, Finn TS, Abramson MA: Ertapenem versus cefotetan prophylaxis in elective colorectal surgery. N Engl J Med 2006, 355:2640-2651.
• [15]Milsom JW, Smith DL, Corman ML, Howerton RA, Yellin AE, Luke DR: Double-blind comparison of single-dose alatrofloxacin and cefotetan as prophylaxis of infection following elective colorectal surgery. Trovafloxacin Surgical Group. Am J Surg 1998, 176(Suppl):46-52.
• [16]Arnaud JP, Bellissant E, Boissel P, Carlet J, Chastang C, Lafaix C, Rio Y, Berganeschi R: Single-dose amoxycillin-clavulanic acid vs. cefotetan for prophylaxis in elective colorectal surgery: a multicentre, prospective, randomized study. The PRODIGE Group. J Hosp Infect 1992, 22(Suppl A):23-32.
• [17]Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG, Foley EF: Wound infection after elective colorectal resection. Ann Surg 2004, 239:599-605.
• [18]Darouiche RO, Wall MJ, Itani KMF, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH: Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med 2010, 362:18-26.
• [19]Seiler CM, Bruckner T, Diener MK, Papyan A, Golcher H, Seidlmayer C, Franck A, Kieser M, Büchler MW, Knaebel H-P: Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicentre randomized trial (INSECT: ISRCTN24023541). Ann Surg 2009, 249:576-582.
• [20]Bennett-Guerrero E, Pappas TN, Koltun WA, Fleshman JW, Lin M, Garg J, Mark DB, Marcet JE, Remzi FH, George VV, Newland K, Corey GR: Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. N Engl J Med 2010, 363:1038-1049.
• [21]Auerbach AD: Prevention of surgical site infections. In Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Evidence Report/Technology Assessment. Rockville, MD, USA: Agency for Healthcare Research and Quality; 2001:221-244.
• [22]Coello R, Glenister H, Fereres J, Bartlett C, Leigh D, Sedgwick J, Cooke EM: The cost of infection in surgical patients: a case–control study. J Hosp Infect 1993, 25:239-250.
• [23]Kappstein I, Schulgen G, Fraedrich G, Schlosser V, Schumacher M, Daschner FD: Added hospital stay due to wound infections following cardiac surgery. Thorac Cardiovasc Surg 1992, 40:148-151.
• [24]Poulsen KB, Bremmelgaard A, Sørensen AI, Raahave D, Petersen JV: Estimated costs of postoperative wound infections. A case–control study of marginal hospital and social security costs. Epidemiol Infect 1994, 113:283-295.
• [25]Merle V, Germain JM, Chamouni P, Daubert H, Froment L, Michot F, Teniere P, Czernichow P: Assessment of prolonged hospital stay attributable to surgical site infections using appropriateness evaluation protocol. Am J Infect Control 2000, 28:109-115.
• [26]Fry DE: The economic costs of surgical site infection. Surg Infect (Larchmt) 2002, 3(Suppl 1):S37-S43.
• [27]de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB: Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control 2009, 37:387-397.
• [28]Broex ECJ, van Asselt ADI, Bruggeman CA, van Tiel FH: Surgical site infections: how high are the costs? J Hosp Infect 2009, 72:193-201.
• [29]KISS: Surveillance System postoperative Wundinfektionen. http://www.nrz-hygiene.de/surveillance/kiss/ webcite]
• [30]Reid K, Pockney P, Draganic B, Smith SR: Barrier wound protection decreases surgical site infection in open elective colorectal surgery: a randomized clinical trial. Dis Colon Rectum 2010, 53:1374-1380.
• [31]Horiuchi T, Tanishima H, Tamagawa K, Matsuura I, Nakai H, Shouno Y, Tsubakihara H, Inoue M, Tabuse K: Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites. J Trauma 2007, 62:212-215.
• [32]Sookhai S, Redmond HP, Deasy JM: Impervious wound-edge protector to reduce postoperative wound infection: a randomised, controlled trial. Lancet 1999, 353:1585.
• [33]Kato Y, Marusasa T, Ichikawa S, Lane GJ, Okazaki T, Yamataka A: Lapprotector use decreases incisional wound infections in cases of perforated appendicitis: a prospective study. Asian J Surg 2008, 31:101-103.
• [34]Psaila JV, Wheeler MH, Crosby DL: The role of plastic wound drapes in the prevention of wound infection following abdominal surgery. Br J Surg 1977, 64:729-732.
• [35]Kercher KW, Nguyen TH, Harold KL, Poplin ME, Matthews BD, Sing RF, Heniford BT: Plastic wound protectors do not affect wound infection rates following laparoscopic-assisted colectomy. Surg Endosc 2004, 18:148-151.
• [36]Nyström PO, Broomé A, Höjer H, Ling L: A controlled trial of a plastic wound ring drape to prevent contamination and infection in colorectal surgery. Dis Colon Rectum 1984, 27:451-453.
• [37]Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S: Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg 2011, 146:263-269.
• [38]Fairclough JA, Johnson D, Mackie I: The prevention of wound contamination by skin organisms by the pre-operative application of an iodophor impregnated plastic adhesive drape. J Int Med Res 1986, 14:105-109.
• [39]Yoshimura Y, Kubo S, Hirohashi K, Ogawa M, Morimoto K, Shirata K, Kinoshita H: Plastic iodophor drape during liver surgery operative use of the iodophor-impregnated adhesive drape to prevent wound infection during high risk surgery. World J Surg 2003, 27:685-688.
• [40]Chiu KY, Lau SK, Fung B, Ng KH, Chow SP: Plastic adhesive drapes and wound infection after hip fracture surgery. Aust N Z J Surg 1993, 63:798-801.
• [41]Dewan PA, Van Rij AM, Robinson RG, Skeggs GB, Fergus M: The use of an iodophor-impregnated plastic incise drape in abdominal surgery-a controlled clinical trial. Aust N Z J Surg 1987, 57:859-863.
• [42]Webster J, Alghamdi A: Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database Syst Rev 2007, 4:CD006353.
• [43]Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R: Transection of the oesophagus for bleeding oesophageal varices. Br J Surg 1973, 60:646-649.
• [44]International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH E6. Harmonised Guideline for Good Clinical Practice. Geneva, Switzerland: ICH; 1996.
• [45]Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P: CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 2003, 13:176-181.
• [46]Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS: Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med 1991, 91:152-157.
• [47]van Buuren S: Multiple imputation of discrete and continuous data by fully conditional specification. Stat Methods Med Res 2007, 16:219-242.
• [48]O’Brien PC, Fleming TR: A multiple testing procedure for clinical trials. Biometrics 1979, 35:549-556.
• [49]International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH E9. Statistical Principles for Clinical Trials. Geneva, Switzerland: ICH; 1998.
• [50]World Medical Association: Declaration of Helsinki - Ethical principles for medical research involving human subjects. Proceedings of the 59th WMA General Assembly, Seoul, Korea, October 2008;
• [51]Alexander JW, Solomkin JS, Edwards MJ: Updated recommendations for control of surgical site infections. Ann Surg 2011, 253:1082-1093.
• [52]Melling AC, Ali B, Scott EM, Leaper DJ: Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial. Lancet 2001, 358:876-880.
• [53]Kurz A, Sessler DI, Lenhardt R: Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med 1996, 334:1209-1215.