Effect of Active Warming on Surgical Site Infections

Surgical Site Infection Clinical Trial

Official title:

The Effect of Maintenance of Normothermia With Active Warming on Surgical Site Infections in Patients Undergoing Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187378
• Other study ID #: 31102019-15/III
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2022
• Source: Istanbul University-Cerrahpasa
• Contact: Cemile Çelebi, M.Sc.
• Phone: +905547276385
• Email: ccelebi48[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of active warming by maintaining the normothermia during abdominal surgical procedures. The investigators hypothesize that there is no difference in terms of preventing surgical site infections between warm air blown surgical access blanket and underbody blanket.

Description:

Hypothermia is defined as a body temperature below 36°C and classified as mild (34°C-36°C), moderate (32°C-33.9°C), severe (<32°C) hypothermia. Hypothermia can be caused by reduced heat production, increased heat loss and / or deterioration of thermoregulation (anesthesia and premedication drugs, antiseptic solutions, low ambient temperature, wet surgical sterile drapes on the patient, use of cold intravenous fluids). Preoperative, intraoperative and postoperative hypothermia is the drop of body temperature below 36 ° C within one hour before surgery and within 24 hours postoperatively. It is the most common but preventable thermal disorder during anesthesia. It occurs as a result of anesthesia on thermoregulation during surgery and exposure to cold operating room. Although it can be seen in all anesthetized individuals before, during and after surgery due to age, sex, body surface area and body shape; duration, depth, signs and symptoms may vary. The American Society of Operating Room Nurses (AORN) emphasized the importance of the use of appropriate heating devices in the prevention of hypothermia in surgical patients. Experimental studies and meta-analyzes indicate that active methods of preventing hypothermia (hot air blown systems, hot water circulating blankets and garments, liquid heaters, blood and blood product heaters, etc.), passive methods (wool and synthetic woolen materials, garments and blankets, insulation) materials, etc.) are more effective. It is recommended to use more than one method together to maintain normothermia before, during and after surgery. Hypothermia is an important problem that should be prevented in surgical patient because it causes serious problems such as delayed wound healing, bleeding, cardiac problems, deterioration of patient comfort, prolonged hospital stay, surgical site infection (SSI) and deaths. Many guidelines state that the risk of surgical site infection increases three fold due to a decrease in central temperature of 1.9 C. According to the Guidelines for Safe Surgery published by the World Health Organization in 2009; maintaining normothermia during surgery is one of the ten steps intended to reduce the incidence of postoperative surgical site infection. The National Institute for Health and Care Excellence and the Association for Enhanced Recovery After Surgery (ERAS) recommend the maintenance of intraoperative normothermia to prevent surgical site infection. Surgical nurse; should be aware of the causes of hypothermia and the complications that may occur during the planning, implementation and evaluation of a patient-specific, multi-faceted care; should check the body temperature before, during and after surgery and take precautions to prevent body temperature. Therefore, the body temperature of the patient should be monitored at regular intervals, the body temperature of the preventive interventions must be timely and effective implementation. The maintenance of normothermia in patients with perioperative procedures may reduce the incidence of complications due to hypothermia and may have a positive effect on the success and recovery of surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 1, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with American Society of Anesthesiologists score I-II-III,
• 18-70 years old,
• Patients undergoing abdominal surgery (ventral hernia)
• Patients whose operation lasts longer than 30 minutes and less than 3 hours

Exclusion Criteria:

• Patients with American Society of Anesthesiologists score IV-V
• Patients with morbid obese (BMI> 40kg / m^2)
• Patients with neurological, psychiatric, neuromuscular disease
• Alcohol and drug addict patients
• Mental retarded patients
• Patients taking medications that affect thermoregulation, such as vasodilators
• Patients with a history of thyroid disease
• Pregnant women
• Patients undergoing pre-intra-post-blood transfusion
• Patients with blood glucose levels above 200 mg / dl

Related Conditions & MeSH terms

• Communicable Diseases
• Hernia, Ventral
• Infections
• Surgical Site Infection
• Surgical Wound Infection
• Ventral Hernia

Intervention

Device:
• Surgical Underbody Blanket
Surgical blanket is used to maintain normothermia during abdominal surgery
• Surgical access blanket
Surgical blanket is used to maintain normothermia during abdominal surgery

Locations

Country	Name	City	State
Turkey	Mugla Sitki Koçman University Training and Research Hospital	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Batsis JA, Naessens JM, Keegan MT, Huddleston PM, Wagie AE, Huddleston JM. Body mass index and the impact on hospital resource use in patients undergoing total knee arthroplasty. J Arthroplasty. 2010 Dec;25(8):1250-7.e1. doi: 10.1016/j.arth.2009.09.009. Epub 2010 Feb 19. — View Citation

Bender M, Self B, Schroeder E, Giap B. Comparing new-technology passive warming versus traditional passive warming methods for optimizing perioperative body core temperature. AORN J. 2015 Aug;102(2):183.e1-8. doi: 10.1016/j.aorn.2015.06.005. — View Citation

Cooper S. The effect of preoperative warming on patients' postoperative temperatures. AORN J. 2006 May;83(5):1073-6, 1079-84; quiz 1085-8. Review. — View Citation

Deren ME, Machan JT, DiGiovanni CW, Ehrlich MG, Gillerman RG. Prewarming operating rooms for prevention of intraoperative hypothermia during total knee and hip arthroplasties. J Arthroplasty. 2011 Dec;26(8):1380-6. doi: 10.1016/j.arth.2010.12.019. Epub 2011 Feb 12. — View Citation

Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(®)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y. Review. — View Citation

Hart SR, Bordes B, Hart J, Corsino D, Harmon D. Unintended perioperative hypothermia. Ochsner J. 2011 Fall;11(3):259-70. — View Citation

Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. — View Citation

Marino M, Masella R, Bulzomi P, Campesi I, Malorni W, Franconi F. Nutrition and human health from a sex-gender perspective. Mol Aspects Med. 2011 Feb;32(1):1-70. doi: 10.1016/j.mam.2011.02.001. Epub 2011 Feb 26. Review. — View Citation

Savage JW, Anderson PA. An update on modifiable factors to reduce the risk of surgical site infections. Spine J. 2013 Sep;13(9):1017-29. doi: 10.1016/j.spinee.2013.03.051. Epub 2013 May 24. Review. — View Citation

Sessler DI. Mild perioperative hypothermia. N Engl J Med. 1997 Jun 12;336(24):1730-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection Rate	The rate of surgical site infection will be monitored for each group by the case doctor and principle investigator. The patients will be diagnosed as Surgical Site Infection (SSI) according to CDC Guidelines if there is purulent wound drainage or serous but wound culture is positive within the postoperative 30 days.	Within the postoperative 30 days
Secondary	Body Temperature	Before surgery, surgical access blanket or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an tympanic thermometer every 15 minutes during surgery and 2 hours after surgery. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm.	During the surgery and 2 hours after surgery (up to 300 minutes)
Secondary	Duration of surgery	Minutes from skin incision until skin closure	Day 0 (day of surgery)

External Links

•   Peri-operative hypothermia: implications for practice
•   Surgical site infections: prevention and treatment
•   The Essentials of Maintaining Patient Normothermia