Skip to main content
OpenTrials
Completed

NCT Number: NCT05548764

Prevention Bundles for SSIs (PREBUSSI).

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hippocration General Hospital

Athens, Greece

About this study

  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevention Bundles for SSIs

Procedure

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

Primary outcomes

  1. Incidence of SSIs

    Time frame: 30 days

    Rate of SSIs after implementation of prevention bundles

Secondary outcomes

  1. Length of hospital stay

    Time frame: 30 days

    Days of hospitalization.

  2. Cost

    Time frame: 30 days

    Overall cost of procedures and hospitalization.

  3. Pathogen cultures

    Time frame: 30 days

    Results of pathogen cultures.

  4. Antibiotic sensitivity test

    Time frame: 30 days

    Antibiotics in which cultured pathogens are sensitive.

  5. Implementation of guidelines

    Time frame: 30 days

    Adoptive efficacy of the 10 preventive bundles.

Sponsors and collaborators

Lead sponsor

Maximos Frountzas

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2022
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.