Effect of Standard Normothermia Protocol On Surgical Site Infections
13. november 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
118
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
|
|
|
Aktiv komparator: Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Surgical Site Infection Rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maintaining Normothermia Rate
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Mustafa Cem Terzi, Proffessor Doctor, Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2013
Primær fullføring (Faktiske)
1. desember 2015
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
1. november 2016
Først innsendt som oppfylte QC-kriteriene
9. november 2016
Først lagt ut (Anslag)
10. november 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. november 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 870-GOA
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .