NCT05548764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

September 17, 2022

Last Update Submit

December 27, 2023

Conditions

Surgical Site Infection

Keywords

SSIpreventionbundlesPREBUSSI

Outcome Measures

Primary Outcomes (1)

  • Incidence of SSIs

    Rate of SSIs after implementation of prevention bundles

    30 days

Secondary Outcomes (5)

  • Length of hospital stay

    30 days

  • Cost

    30 days

  • Pathogen cultures

    30 days

  • Antibiotic sensitivity test

    30 days

  • Implementation of guidelines

    30 days

Study Arms (2)

Prevention Bundles

Patients in which prevention bundles for SSIs have been implemented.

Procedure: Prevention Bundles for SSIs

No Prevention Bundles

Patients in which prevention bundles for SSIs have not been implemented.

Interventions

Prevention Bundles for SSIsPROCEDURE

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

Prevention Bundles

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that underwent abdominal surgery.

You may qualify if:

  • Age ≥ 18 years old
  • Signed consent from patient or authorized representative
  • Abdominal surgery
  • Open or laparoscopic operations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hippocration General Hospital

Athens, Greece

Location

Related Publications (5)

  • 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.

    PMID: 32001865BACKGROUND

  • 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.

    PMID: 32586351BACKGROUND

  • 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.

    PMID: 32812136BACKGROUND

  • 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.

    PMID: 34774274BACKGROUND

  • 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.

    PMID: 32674555BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Konstantinos G Toutouzas, MD PhD

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Maximos Frountzas MD MPA PhD

Study Record Dates

First Submitted

September 17, 2022

First Posted

September 21, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

December 20, 2023

Last Updated

December 28, 2023

Record last verified: 2023-12

Locations

GR(1)