Prevention Bundles for SSIs (PREBUSSI).

Surgical Site Infection Clinical Trial

Official title: Prevention Bundles for Surgical Site Infections (PREBUSSI): a Multi-center Observational Study.

Status Completed

Clinical Trial Summary

Surgical site infections (SSIs) are the most complication after a surgical operation and their incidence reaches 20% worldwide. SSIs have been associated to significant morbidity and mortality, high ICU admission rates, increased length of hospital stay, high readmission rates and raised cost. However, there is no registry for SSIs in Greece so far. In addition, it has been considered that almost half of SSIs could be prevented. Therefore, several prevention strategies have been suggested by international health organizations, such as WHO and NICE, that seem to be effective. The aim of the present study is to investigate the effect of 10 prevention bundles on the rate of SSIs, as well their consequences on several financial parameters of the Greek healthcare system.

Clinical Trial Description

• 1st phase (2 months) → SSIs rate among abdominal surgical operations and reporting of patients' demographics (gender, age, comorbidities), type of surgery (upper GI, HPB, colorectal), surgical approach (open, laparoscopic), urgency classification, operation time, cost, pathogen cultures and antibiotic sensitivity test.

• 2ο phase (10 months) → implementation of 10 prevention bundles:

1. Antibiotic delivery 1-1.5 hours before surgical incision and repeat every 4 hours intraoperatively.

2. Hair removal with electric hair clippers using single-use bladdes.

3. Surgical scrub with Povidone Iodine solution 4% (Betadine Surgical Scrub)

4. Skin preparation with chlorexidine alcohol-based antiseptic solution 2%.

5. Intraoperative and postoperative (4-6 hours) normothermia (>36οC) using warmed forced-air blankets.

6. Perioperative normoglycemia (Glu<200mg/dl) in diabetic patients.

7. Single-use drapes and gowns.

8. Surgical team glove changing by before skin incision closing.

9. Single-layer surgical incision closure with triclosan plus antimicrobial-coated sutures.

10. Wound irrigation (skin and subcutaneous fat) with Povidone Iodine solution (Betadine) after abdominal wall closure.

• Implementation check of 10 prevention bundles preoperatively, intraoperatively and postoperatively.

• Clinical assessment on POD 1, 3, 7 and 1 month postoperatively for SSI presence (according to WHO 2018 definition).

• Reporting of patients' demographics (gender, age, comorbidities), type of surgery (upper GI, HPB, colorectal), surgical approach (open, laparoscopic), urgency classification, operation time, length of stay, cost, pathogen cultures and antibiotic sensitivity test. ;

Related Conditions & MeSH terms

• Infections
• Surgical Site Infection
• Surgical Wound Infection

• NCT number: NCT05548764
• Study type: Observational
• Source: National and Kapodistrian University of Athens
• Status: Completed
• Start date: October 1, 2022
• Completion date: December 20, 2023