N/A
N=128
Effect of Standard Normothermia Protocol On Surgical Site Infections
Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT02961244 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Surgical Site Infection Rate — 19; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prewarming and perioperative warming with Forced Air Warming device and its blankets. (Other); Forced Air Warming blanket (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dokuz Eylul University
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Site Infection Rate |
19; 8 | — |
| SECONDARY Maintaining Normothermia Rate |
7; 26 | — |
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
Data sourced from ClinicalTrials.gov (NCT02961244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.