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Effect of Active Warming on Surgical Site Infections

Primary Purpose

Surgical Site Infection, Ventral Hernia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Surgical Underbody Blanket
Surgical access blanket
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Hypothermia, Surgical Wound Infection, Herniorrhaphy, Nursing care

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muğla Sıtkı Koçman University Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Underbody Blanket Group

Surgical Access Blanket Group

Arm Description

Body temperature of the patients will be measured in the pre-operative service and in the waiting room. Sociodemographic characteristics form, preoperative, intra and postoperative evaluation forms will be completed. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form.

Patients with hypothermia (<36C) will be warmed by air blown underbody blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form.

Patients with hypothermia (<36C) will be warmed by air blown surgical access blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Duration of surgery
Minutes from skin incision until skin closure

Full Information

First Posted
November 26, 2019
Last Updated
March 31, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04187378
Brief Title
Effect of Active Warming on Surgical Site Infections
Official Title
The Effect of Maintenance of Normothermia With Active Warming on Surgical Site Infections in Patients Undergoing Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
August 11, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Ventral Hernia
Keywords
Hypothermia, Surgical Wound Infection, Herniorrhaphy, Nursing care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Body temperature of the patients will be measured in the pre-operative service and in the waiting room. Sociodemographic characteristics form, preoperative, intra and postoperative evaluation forms will be completed. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form.
Arm Title
Underbody Blanket Group
Arm Type
Experimental
Arm Description
Patients with hypothermia (<36C) will be warmed by air blown underbody blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form.
Arm Title
Surgical Access Blanket Group
Arm Type
Experimental
Arm Description
Patients with hypothermia (<36C) will be warmed by air blown surgical access blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form.
Intervention Type
Device
Intervention Name(s)
Surgical Underbody Blanket
Intervention Description
Surgical blanket is used to maintain normothermia during abdominal surgery
Intervention Type
Device
Intervention Name(s)
Surgical access blanket
Intervention Description
Surgical blanket is used to maintain normothermia during abdominal surgery
Primary Outcome Measure Information:
Title
Surgical Site Infection Rate
Description
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.
Time Frame
Within the postoperative 30 days
Secondary Outcome Measure Information:
Title
Body Temperature
Description
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.
Time Frame
During the surgery and 2 hours after surgery (up to 300 minutes)
Title
Duration of surgery
Description
Minutes from skin incision until skin closure
Time Frame
Day 0 (day of surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cemile Çelebi, M.Sc.
Phone
+905547276385
Email
ccelebi48@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İkbal Çavdar, Professor
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Muğla Sıtkı Koçman University Training and Research Hospital
City
Muğla
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cemile Çelebi, M.Sc.
Phone
905547276385
Email
ccelebi48@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20171045
Citation
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Results Reference
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26227528
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.
Results Reference
background
PubMed Identifier
16722285
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. doi: 10.1016/s0001-2092(06)60118-x.
Results Reference
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PubMed Identifier
21316914
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.
Results Reference
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PubMed Identifier
21960760
Citation
Hart SR, Bordes B, Hart J, Corsino D, Harmon D. Unintended perioperative hypothermia. Ochsner J. 2011 Fall;11(3):259-70.
Results Reference
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PubMed Identifier
1610573
Citation
Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. doi: 10.1016/0952-8180(92)90064-8.
Results Reference
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PubMed Identifier
21356234
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.
Results Reference
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PubMed Identifier
23711958
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.
Results Reference
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PubMed Identifier
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Citation
Sessler DI. Mild perioperative hypothermia. N Engl J Med. 1997 Jun 12;336(24):1730-7. doi: 10.1056/NEJM199706123362407. No abstract available.
Results Reference
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PubMed Identifier
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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(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
Results Reference
background
Links:
URL
https://journals.rcni.com/nursing-standard/perioperative-hypothermia-implications-for-practice-ns2013.07.27.45.33.e7742
Description
Peri-operative hypothermia: implications for practice
URL
https://www.nice.org.uk/guidance/cg74
Description
Surgical site infections: prevention and treatment

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Effect of Active Warming on Surgical Site Infections

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