Effect of Standard Normothermia Protocol On Surgical Site Infections
13 de noviembre de 2017 actualizado por: Ali Kadir Değirmenci, Dokuz Eylul University
Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial
Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
118
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Elective
- Preoperatively not infected/dirty Surgical Site
- Open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes)
Exclusion Criteria:
- Emergent surgery
- Local/locoregional procedures
- Laparoscopic operation
- Minor abdominal operations (e.g. hernia repair, colostomy closure)
- Malign hyperthermia
- Signs of active infection or fever
- Immunosuppression
- Severe malnutrition
- Kidney/liver failure and antibiotic use within the previous 1 week or immunosuppressive use (chemotherapy, steroids.) within the previous 1 month and reversal of patients opinion while randomization period
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
|
|
|
Comparador activo: Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Surgical Site Infection Rate
Periodo de tiempo: Postoperative 30 days
|
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. All patients were made enough incision wide to explore their entire abdomen defined as "Major Abdominal Surgery" . With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n<30), (p=0.044 chi-square ) |
Postoperative 30 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maintaining Normothermia Rate
Periodo de tiempo: Surgery day
|
Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed. With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was <36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia) |
Surgery day
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Mustafa Cem Terzi, Proffessor Doctor, Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998 Jan;36(1):8-27. doi: 10.1097/00005650-199801000-00004.
- 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 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.
- 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 Sep 15;358(9285):876-80. doi: 10.1016/S0140-6736(01)06071-8. Erratum In: Lancet 2002 Mar 9;359(9309):896.
- Horn EP, Bein B, Bohm R, Steinfath M, Sahili N, Hocker J. The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia. Anaesthesia. 2012 Jun;67(6):612-7. doi: 10.1111/j.1365-2044.2012.07073.x. Epub 2012 Feb 29.
- Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.
- 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.
- Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.
- Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
- Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
- Polderman KH. Mechanisms of action, physiological effects, and complications of hypothermia. Crit Care Med. 2009 Jul;37(7 Suppl):S186-202. doi: 10.1097/CCM.0b013e3181aa5241.
- 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 Epidemiol. 1992 Oct;13(10):606-8. No abstract available.
- Leslie K, Sessler DI. Perioperative hypothermia in the high-risk surgical patient. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):485-98. doi: 10.1016/s1521-6896(03)00049-1.
- Esnaola NF, Cole DJ. Perioperative normothermia during major surgery: is it important? Adv Surg. 2011;45:249-63. doi: 10.1016/j.yasu.2011.03.007.
- de Brito Poveda V, Clark AM, Galvao CM. A systematic review on the effectiveness of prewarming to prevent perioperative hypothermia. J Clin Nurs. 2013 Apr;22(7-8):906-18. doi: 10.1111/j.1365-2702.2012.04287.x. Epub 2012 Sep 17.
- Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.
- Putzu M, Casati A, Berti M, Pagliarini G, Fanelli G. Clinical complications, monitoring and management of perioperative mild hypothermia: anesthesiological features. Acta Biomed. 2007 Dec;78(3):163-9.
- Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. doi: 10.1016/s1521-6896(03)00052-1.
- Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. doi: 10.1016/j.bpa.2007.10.004.
- Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.
- Forbes SS, Eskicioglu C, Nathens AB, Fenech DS, Laflamme C, McLean RF, McLeod RS; Best Practice in General Surgery Committee, University of Toronto. Evidence-based guidelines for prevention of perioperative hypothermia. J Am Coll Surg. 2009 Oct;209(4):492-503.e1. doi: 10.1016/j.jamcollsurg.2009.07.002. Epub 2009 Aug 20. No abstract available.
- Melton GB, Vogel JD, Swenson BR, Remzi FH, Rothenberger DA, Wick EC. Continuous intraoperative temperature measurement and surgical site infection risk: analysis of anesthesia information system data in 1008 colorectal procedures. Ann Surg. 2013 Oct;258(4):606-12; discussion 612-3. doi: 10.1097/SLA.0b013e3182a4ec0f.
- Byrne DJ, Malek MM, Davey PG, Cuschieri A. Postoperative wound scoring. Biomed Pharmacother. 1989;43(9):669-73. doi: 10.1016/0753-3322(89)90085-1.
- Sessler DI. Perioperative thermoregulation. Geriatr Anesthesiol. 2008;6736(15):107-22
- Horosz B, Malec-Milewska M. Inadvertent intraoperative hypothermia. Anaesthesiol Intensive Ther. 2013 Jan-Mar;45(1):38-43. doi: 10.5603/AIT.2013.0009.
- Clinical practice guideline: The management of inadvertent perioperative hypothermia in adults National Collaborating Centre for Nursing and Supportive Care commissioned by National Institute for Health and Clinical Excellence. 2008;88-92, 204-445
- Leslie K, Sessler DI, Bjorksten AR, Moayeri A. Mild hypothermia alters propofol pharmacokinetics and increases the duration of action of atracurium. Anesth Analg. 1995 May;80(5):1007-14. doi: 10.1097/00000539-199505000-00027.
- Fritz HG, Holzmayr M, Walter B, Moeritz KU, Lupp A, Bauer R. The effect of mild hypothermia on plasma fentanyl concentration and biotransformation in juvenile pigs. Anesth Analg. 2005 Apr;100(4):996-1002. doi: 10.1213/01.ANE.0000146517.17910.54.
- Liu M, Hu X, Liu J. The effect of hypothermia on isoflurane MAC in children. Anesthesiology. 2001 Mar;94(3):429-32. doi: 10.1097/00000542-200103000-00011.
- Mauermann WJ, Nemergut EC. The anesthesiologist's role in the prevention of surgical site infections. Anesthesiology. 2006 Aug;105(2):413-21; quiz 439-40. doi: 10.1097/00000542-200608000-00025. No abstract available. Erratum In: Anesthesiology. 2006 Oct;105(4):868.
- Wenisch C, Narzt E, Sessler DI, Parschalk B, Lenhardt R, Kurz A, Graninger W. Mild intraoperative hypothermia reduces production of reactive oxygen intermediates by polymorphonuclear leukocytes. Anesth Analg. 1996 Apr;82(4):810-6. doi: 10.1097/00000539-199604000-00023.
- Barie PS. Surgical site infections: epidemiology and prevention. Surg Infect (Larchmt). 2002;3 Suppl 1:S9-21. doi: 10.1089/sur.2002.3.s1-9.
- Arslan NC, Terzi C, Kaya Ozlem, et. al. Perioperative Body Temperature: One Day Prevalence Study İn One Hospital. XVI. Annual Meeting of the European Society of Surgery Abstract Book 2012; 667-886
- Thiele RH, Huffmyer JL, Nemergut EC. The "six sigma approach" to the operating room environment and infection. Best Pract Res Clin Anaesthesiol. 2008 Sep;22(3):537-52. doi: 10.1016/j.bpa.2008.06.002.
- Wong PF, Kumar S, Bohra A, Whetter D, Leaper DJ. Randomized clinical trial of perioperative systemic warming in major elective abdominal surgery. Br J Surg. 2007 Apr;94(4):421-6. doi: 10.1002/bjs.5631.
- Llewellyn L. Effect of Pre-warming on Reducing the Incidence of Inadvertent Peri-operative Hypothermia for Patients Undergoing General Anaesthesia: A Mini-review. Br J Anaesth Recover Nurs. 2013;14(1-2):3-10
- Flores-Maldonado A, Medina-Escobedo CE, Rios-Rodriguez HM, Fernandez-Dominguez R. Mild perioperative hypothermia and the risk of wound infection. Arch Med Res. 2001 May-Jun;32(3):227-31. doi: 10.1016/s0188-4409(01)00272-7.
- Barone JE, Tucker JB, Cecere J, Yoon MY, Reinhard E, Blabey RG Jr, Lowenfels AB. Hypothermia does not result in more complications after colon surgery. Am Surg. 1999 Apr;65(4):356-9.
- Lehtinen SJ, Onicescu G, Kuhn KM, Cole DJ, Esnaola NF. Normothermia to prevent surgical site infections after gastrointestinal surgery: holy grail or false idol? Ann Surg. 2010 Oct;252(4):696-704. doi: 10.1097/SLA.0b013e3181f6c2a9.
- Pu Y, Cen G, Sun J, Gong J, Zhang Y, Zhang M, Wu X, Zhang J, Qiu Z, Fang F. Warming with an underbody warming system reduces intraoperative hypothermia in patients undergoing laparoscopic gastrointestinal surgery: a randomized controlled study. Int J Nurs Stud. 2014 Feb;51(2):181-9. doi: 10.1016/j.ijnurstu.2013.05.013. Epub 2013 Jun 17.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2013
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
1 de noviembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
9 de noviembre de 2016
Publicado por primera vez (Estimar)
10 de noviembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de diciembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
13 de noviembre de 2017
Última verificación
1 de noviembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 870-GOA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .