Effect of Standard Normothermia Protocol On Surgical Site Infections

Study Overview
=================
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.

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

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.
* Device: Forced Air Warming blanket


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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<br>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.<br> <br> Device: Forced Air Warming blanket<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ) | Postoperative 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Surgery day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical Site Infection, normothermia, hypothermia, prewarming