Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2022-10-01
2023-12-20
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Prevention Bundles
Patients in which prevention bundles for SSIs have been implemented.
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.
No Prevention Bundles
Patients in which prevention bundles for SSIs have not been implemented.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Signed consent from patient or authorized representative
3. Abdominal surgery
4. Open or laparoscopic operations
Exclusion Criteria
2. No signed consent from patient or authorized representative
3. Neck, thoracic, anal, lumbar operations
4. No closure of abdominal wall or open abdomen
18 Years
99 Years
ALL
No
Sponsors
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Maximos Frountzas
OTHER
Responsible Party
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Maximos Frountzas
Maximos Frountzas MD MPA PhD
Principal Investigators
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Konstantinos G Toutouzas, MD PhD
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistrian University of Athens
Locations
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Hippocration General Hospital
Athens, , Greece
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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PREBUSSI 2022
Identifier Type: -
Identifier Source: org_study_id