Prevention Bundles for SSIs (PREBUSSI).

Completed

• Conditions: Surgical Site Infection
• Interventions: Procedure: Prevention Bundles for SSIs

• Registration Number: NCT05548764
• Lead Sponsor: Maximos Frountzas

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-09-17
• Study First Submitted QC: 2022-09-17
• Study First Posted: 2022-09-21
• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Status Verified: 2023-12
• Study Completion: 2023-12-20
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age ≥ 18 years old
2. Signed consent from patient or authorized representative
3. Abdominal surgery
4. Open or laparoscopic operations

Exclusion Criteria

1. Age < 18 years old
2. No signed consent from patient or authorized representative
3. Neck, thoracic, anal, lumbar operations
4. No closure of abdominal wall or open abdomen

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prevention Bundles	Prevention Bundles for SSIs	Patients in which prevention bundles for SSIs have been implemented.

Primary Outcome Measures

Name	Time	Method
Incidence of SSIs	30 days	Rate of SSIs after implementation of prevention bundles

Secondary Outcome Measures

Name	Time	Method
Cost	30 days	Overall cost of procedures and hospitalization.
Pathogen cultures	30 days	Results of pathogen cultures.
Antibiotic sensitivity test	30 days	Antibiotics in which cultured pathogens are sensitive.
Length of hospital stay	30 days	Days of hospitalization.
Implementation of guidelines	30 days	Adoptive efficacy of the 10 preventive bundles.

Trial Locations

Locations (1)

Hippocration General Hospital; 🇬🇷 Athens, Greece