Effect of Standard Normothermia Protocol On Surgical Site Infections
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring Surgical Site Infection, normothermia, hypothermia, prewarming
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
Intervention Group
Arm Description
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Outcomes
Primary Outcome Measures
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 )
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT02961244
First Posted
November 1, 2016
Last Updated
November 13, 2017
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT02961244
Brief Title
Effect of Standard Normothermia Protocol On Surgical Site Infections
Official Title
Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Surgical Site Infection, normothermia, hypothermia, prewarming
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Intervention Type
Other
Intervention Name(s)
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Intervention Type
Device
Intervention Name(s)
Forced Air Warming blanket
Primary Outcome Measure Information:
Title
Surgical Site Infection Rate
Description
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 )
Time Frame
Postoperative 30 days
Secondary Outcome Measure Information:
Title
Maintaining Normothermia Rate
Description
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)
Time Frame
Surgery day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Cem Terzi, Proffessor Doctor
Organizational Affiliation
Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Effect of Standard Normothermia Protocol On Surgical Site Infections
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