Prevention Bundles for SSIs (PREBUSSI).

Study Overview
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Brief Summary
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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
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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: Antibiotic delivery 1-1.5 hours before surgical incision and repeat every 4 hours intraoperatively. Hair removal with electric hair clippers using single-use bladdes. Surgical scrub with Povidone Iodine solution 4% (Betadine Surgical Scrub) Skin preparation with chlorexidine alcohol-based antiseptic solution 2%. Intraoperative and postoperative (4-6 hours) normothermia (>36οC) using warmed forced-air blankets. Perioperative normoglycemia (Glu<200mg/dl) in diabetic patients. Single-use drapes and gowns. Surgical team glove changing by before skin incision closing. Single-layer surgical incision closure with triclosan plus antimicrobial-coated sutures. 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.

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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Procedure: Prevention Bundles for SSIs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Signed consent from patient or authorized representative Abdominal surgery Open or laparoscopic operations Exclusion Criteria: Age < 18 years old No signed consent from patient or authorized representative Neck, thoracic, anal, lumbar operations No closure of abdominal wall or open abdomen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prevention Bundles<br>Patients in which prevention bundles for SSIs have been implemented. | Procedure: Prevention Bundles for SSIs<br>* 10 preoperative, intraoperative and postoperative bundles that aim to decrease SSIs rate after their implementation in patients that underwent abdominal surgery.<br>|
| No Prevention Bundles<br>Patients in which prevention bundles for SSIs have not been implemented. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SSIs | Rate of SSIs after implementation of prevention bundles | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SSI, prevention, bundles, PREBUSSI