Effect of Standard Normothermia Protocol On Surgical Site Infections

Not Applicable

Completed

• Conditions: Surgical Site Infection
• Interventions: Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.; Device: Forced Air Warming blanket

• Registration Number: NCT02961244
• Lead Sponsor: Dokuz Eylul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-10
• Results First Submitted: 2017-01-06
• Results First Submitted QC: 2017-04-02
• Results First Posted: 2017-05-11
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Forced Air Warming blanket	Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Intervention Group	Prewarming and perioperative warming with Forced Air Warming device and its blankets.	Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection Rate	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 )

Secondary Outcome Measures

Name	Time	Method
Maintaining Normothermia Rate	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)