Effect of Standard Normothermia Protocol On Surgical Site Infections

Dokuz Eylul University118 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

118

Conditions

Surgical Site Infection

Interventions

Prewarming and perioperative warming with Forced Air Warming device and its blankets.OTHER

Forced Air Warming blanketDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 )

Time frame: Postoperative 30 days

Secondary Outcomes

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)

Time frame: Surgery day

Data from ClinicalTrials.gov

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