Clinical trial NCT02961244: 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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: Surgical Site Infection
normothermia
hypothermia
prewarming
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2016-11-10
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Surgical Site Infection Rate
timeFrame: Postoperative 30 days
Secondary outcomes:
measure: Maintaining Normothermia Rate
timeFrame: Surgery day
Other outcomes:
Locations:
Study officials:
affiliation: Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department
name: Mustafa Cem Terzi, Proffessor Doctor
role: STUDY_DIRECTOR
References:
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