Effect of Standard Normothermia Protocol On Surgical Site Infections

Overview

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

Full Title of Study: “Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2015

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: Control Group
    • Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic’s traditional methods except prewarming.
  • Active Comparator: Intervention Group
    • Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dokuz Eylul University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ali Kadir Değirmenci, Asistant Investigator, MD – Dokuz Eylul University
  • Overall Official(s)
    • Mustafa Cem Terzi, Proffessor Doctor, Study Director, Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department

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