Effect of Standard Normothermia Protocol On Surgical Site Infections

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

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Key information

Conditions

Surgical Site Infection Body Temperature Changes Hypothermia Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Forced Air Warming blanket

Device

Primary outcomes

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 )

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2016
First posted: Nov 10, 2016
Registry last updated: Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed