Effect of Standard Normothermia Protocol On Surgical Site Infections

November 13, 2017 updated by: Ali Kadir Değirmenci, Dokuz Eylul University

Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial

Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Active Comparator: Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Device: Forced Air Warming blanket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection Rate
Time Frame: Postoperative 30 days

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 )
Postoperative 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintaining Normothermia Rate
Time Frame: Surgery day

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)
Surgery day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Study Director: Mustafa Cem Terzi, Proffessor Doctor, Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 870-GOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgical Site Infection

Clinical Trials on Prewarming and perioperative warming with Forced Air Warming device and its blankets.

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