Effect of Standard Normothermia Protocol On Surgical Site Infections
NCT ID: NCT02961244
Last Updated: 2017-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2013-06-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
No interventions assigned to this group
Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket
Interventions
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Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket
Eligibility Criteria
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Inclusion Criteria
* Preoperatively not infected/dirty Surgical Site
* Open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Dokuz Eylul University
OTHER
Responsible Party
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Ali Kadir Değirmenci
Asistant Investigator, MD
Principal Investigators
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Mustafa Cem Terzi, Proffessor Doctor
Role: STUDY_DIRECTOR
Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department
References
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Horosz B, Malec-Milewska M. Inadvertent intraoperative hypothermia. Anaesthesiol Intensive Ther. 2013 Jan-Mar;45(1):38-43. doi: 10.5603/AIT.2013.0009.
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.
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
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.
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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.
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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.
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.
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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
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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.
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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.
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.
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Other Identifiers
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870-GOA
Identifier Type: -
Identifier Source: org_study_id