Prevention Bundles for SSIs (PREBUSSI).

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548764
• Other study ID #: PREBUSSI 2022
• Status: Completed
• Start date: October 1, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: December 2023
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 20, 2023
• Est. primary completion date: October 1, 2023
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Procedure:
• Prevention Bundles for SSIs
10 preoperative, intraoperative and postoperative bundles that aim to decrease SSIs rate after their implementation in patients that underwent abdominal surgery.

Locations

Country	Name	City	State
Greece	Hippocration General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Maximos Frountzas

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SSIs	Rate of SSIs after implementation of prevention bundles	30 days
Secondary	Length of hospital stay	Days of hospitalization.	30 days
Secondary	Cost	Overall cost of procedures and hospitalization.	30 days
Secondary	Pathogen cultures	Results of pathogen cultures.	30 days
Secondary	Antibiotic sensitivity test	Antibiotics in which cultured pathogens are sensitive.	30 days
Secondary	Implementation of guidelines	Adoptive efficacy of the 10 preventive bundles.	30 days