Clinical trial NCT05548764: Prevention Bundles for SSIs (PREBUSSI).
Official title: Prevention Bundles for Surgical Site Infections (PREBUSSI): a Multi-center Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Keywords: SSI
prevention
bundles
PREBUSSI
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent abdominal surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of SSIs
timeFrame: 30 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 30 days
measure: Cost
timeFrame: 30 days
measure: Pathogen cultures
timeFrame: 30 days
measure: Antibiotic sensitivity test
timeFrame: 30 days
measure: Implementation of guidelines
timeFrame: 30 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hippocration General Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Konstantinos G Toutouzas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shrestha B, Dunn L. The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision. J Nepal Health Res Counc. 2020 Jan 21;17(4):548-552. doi: 10.33314/jnhrc.v17i4.1042.
citation: Suragul W, Rungsakulkij N, Vassanasiri W, Tangtawee P, Muangkaew P, Mingphruedhi S, Aeesoa S. Predictors of surgical site infection after pancreaticoduodenectomy. BMC Gastroenterol. 2020 Jun 26;20(1):201. doi: 10.1186/s12876-020-01350-8.
citation: Mentor K, Ratnayake B, Akter N, Alessandri G, Sen G, French JJ, Manas DM, Hammond JS, Pandanaboyana S. Meta-Analysis and Meta-Regression of Risk Factors for Surgical Site Infections in Hepatic and Pancreatic Resection. World J Surg. 2020 Dec;44(12):4221-4230. doi: 10.1007/s00268-020-05741-6. Epub 2020 Aug 18.
citation: Fuglestad MA, Tracey EL, Leinicke JA. Evidence-based Prevention of Surgical Site Infection. Surg Clin North Am. 2021 Dec;101(6):951-966. doi: 10.1016/j.suc.2021.05.027.
citation: Lohsiriwat V. High Compliance With Surgical Site Infection (SSI) Prevention Bundle Reduces Incisional SSI After Colorectal Surgery. Ann Coloproctol. 2021 Jun;37(3):146-152. doi: 10.3393/ac.2020.04.10.2. Epub 2020 May 15.