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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
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Surgical Site Infection, normothermia, hypothermia, prewarming

Eligibility Criteria

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

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

    First Posted
    November 1, 2016
    Last Updated
    November 13, 2017
    Sponsor
    Dokuz Eylul University
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    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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