Effect of Standard Normothermia Protocol On Surgical Site Infections

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Surgical Site Infection

Treatments: Device: Forced Air Warming blanket; Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.

Study type: Interventional

Funder types: Other

Identifiers

NCT02961244

870-GOA

Details and patient eligibility

About

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

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Control Group

No Intervention group

Description:

Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.

Intervention Group

Active Comparator group

Description:

Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.

Treatment:

Device: Forced Air Warming blanket

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