Surgical Site InfectionNCT05548764
Prevention Bundles for SSIs (PREBUSSI).
An observational study of Surgical Site Infection, run by Maximos Frountzas at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Prevention Bundles for SSIs
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2022to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients that underwent abdominal surgery.
Who may be able to join
- Age ≥ 18 years old
- Signed consent from patient or authorized representative
- Abdominal surgery
- Open or laparoscopic operations
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention Bundles for Surgical Site Infections (PREBUSSI): a Multi-center Observational Study.
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.
Read the 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:
- 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.
- Conditions
- Surgical Site Infection
- Being tested
- Prevention Bundles for SSIs
- Keywords
- SSI, prevention, bundles, PREBUSSI
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention Bundles for SSIsProcedure or surgery
10 preoperative, intraoperative and postoperative bundles that aim to decrease SSIs rate after their implementation in patients that underwent abdominal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Prevention Bundles | Patients in which prevention bundles for SSIs have been implemented. Receives: Procedure: Prevention Bundles for SSIs | |
| No Prevention Bundles | Patients in which prevention bundles for SSIs have not been implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SSIs
Rate of SSIs after implementation of prevention bundles
Measured: 30 days
Secondary outcomes (5)
Length of hospital stay
Days of hospitalization.
Measured: 30 days
Cost
Overall cost of procedures and hospitalization.
Measured: 30 days
Pathogen cultures
Results of pathogen cultures.
Measured: 30 days
Antibiotic sensitivity test
Antibiotics in which cultured pathogens are sensitive.
Measured: 30 days
Implementation of guidelines
Adoptive efficacy of the 10 preventive bundles.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maximos Frountzas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maximos Frountzas, National and Kapodistrian University of Athens
- Investigators
- Konstantinos G Toutouzas, MD PhD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548764
- Sponsor's protocol ID
- PREBUSSI 2022
- Status last verified
- Dec 2023
- First submitted
- 17 Sep 2022
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32001865Suragul 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.
PubMed 32586351Mentor 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.
PubMed 32812136Fuglestad 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.
PubMed 34774274Lohsiriwat 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.
PubMed 32674555
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Bundles for Surgical Site Infections (PREBUSSI): a Multi-center Observational Study.
- ClinicalTrials.gov ID
- NCT05548764
- Acronym / sponsor ID
- PREBUSSI 2022
- Conditions
- Surgical Site Infection
- Keywords
- SSI, prevention, bundles, PREBUSSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Maximos FrountzasUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention Bundles | – | Procedure: Prevention Bundles for SSIsPatients in which prevention bundles for SSIs have been implemented. |
| No Prevention Bundles | – | –Patients in which prevention bundles for SSIs have not been implemented. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients that underwent abdominal surgery.
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Signed consent from patient or authorized representative
- Abdominal surgery
- Open or laparoscopic operations
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention Bundles for SSIs10 preoperative, intraoperative and postoperative bundles that aim to decrease SSIs rate after their implementation in patients that underwent abdominal surgery. | Procedure or surgery | Prevention Bundles |
Primary outcome
Incidence of SSIs
Time frame: 30 days
Rate of SSIs after implementation of prevention bundles
5 secondary outcomes
Length of hospital stay
Time frame: 30 days
Cost
Time frame: 30 days
Pathogen cultures
Time frame: 30 days
Antibiotic sensitivity test
Time frame: 30 days
Implementation of guidelines
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Background: PubMed 32001865Shrestha 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.
- Background: PubMed 32586351Suragul 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.
- Background: PubMed 32812136Mentor 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.
- Background: PubMed 34774274Fuglestad 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.
- Background: PubMed 32674555Lohsiriwat 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos G Toutouzas, MD PhD principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Maximos Frountzas at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SSIs (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05548764, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.