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Prevention Bundles for SSIs (PREBUSSI).

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05548764
Enrollment
200
Registered
2022-09-21
Start date
2022-10-01
Completion date
2023-12-20
Last updated
2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

SSI, prevention, bundles, PREBUSSI

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.

Interventions

PROCEDUREPrevention Bundles for SSIs

10 preoperative, intraoperative and postoperative bundles that aim to decrease SSIs rate after their implementation in patients that underwent abdominal surgery.

Sponsors

Maximos Frountzas
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of SSIs30 daysRate of SSIs after implementation of prevention bundles

Secondary

MeasureTime frameDescription
Length of hospital stay30 daysDays of hospitalization.
Cost30 daysOverall cost of procedures and hospitalization.
Pathogen cultures30 daysResults of pathogen cultures.
Antibiotic sensitivity test30 daysAntibiotics in which cultured pathogens are sensitive.
Implementation of guidelines30 daysAdoptive efficacy of the 10 preventive bundles.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026