Effect of Standard Normothermia Protocol On Surgical Site Infections

Surgical Site Infection Clinical Trial

Official title:

Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961244
• Other study ID #: 870-GOA
• Status: Completed
• Phase: N/A
• First received: November 1, 2016
• Last updated: November 13, 2017
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2017
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• Prewarming and perioperative warming with Forced Air Warming device and its blankets.

Device:
• Forced Air Warming blanket

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

References & Publications (39)

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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. — View Citation

de Brito Poveda V, Clark AM, Galvão 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. Review. — View Citation

Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. Review. — View Citation

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Flores-Maldonado A, Medina-Escobedo CE, Ríos-Rodríguez HM, Fernández-Domínguez R. Mild perioperative hypothermia and the risk of wound infection. Arch Med Res. 2001 May-Jun;32(3):227-31. — View Citation

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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. — View Citation

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. — View Citation

Horn EP, Bein B, Böhm R, Steinfath M, Sahili N, Höcker 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. — View Citation

Horosz B, Malec-Milewska M. Inadvertent intraoperative hypothermia. Anaesthesiol Intensive Ther. 2013 Jan-Mar;45(1):38-43. doi: 10.5603/AIT.2013.0009. Review. — View Citation

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. — View Citation

Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. Review. — View Citation

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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. — View Citation

Leslie K, Sessler DI. Perioperative hypothermia in the high-risk surgical patient. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):485-98. Review. — View Citation

Liu M, Hu X, Liu J. The effect of hypothermia on isoflurane MAC in children. Anesthesiology. 2001 Mar;94(3):429-32. — View Citation

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

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. — View Citation

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. Review. Erratum in: Anesthesiology. 2006 Oct;105(4):868. — View Citation

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. Erratum in: Lancet 2002 Mar 9;359(9309):896. — View Citation

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. — View Citation

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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. — View Citation

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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. Review. — View Citation

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection Rate	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
Secondary	Maintaining Normothermia Rate	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