Investigation of Environmental Parameters in Operating Rooms

NCT05816135 | Unknown

• 1 other identifier: Getinge study
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative surgical site infection (SSI) is a serious and complicated healthcare-associated infection (HAI) affecting about 2% of patients undergoing orthopedic surgery. Exogenous infections, could occur from insufficient air quality in operating rooms as shown in previous studies. However, from our knowledge, no study have collect environmental parameters and cross referenced the data with recorded patient registries to see if insufficient air quality is associated with higher risk of exogenous SSI. Temperature, humidity and the difference in air pressure in relation to the operating room and the adjacent corridors are examples of environmental parameters that could affect the air quality in operating rooms. Number of persons during an operation and particle counts could also give an indication of insufficient air quality.

Conditions

Surgical Site Infection

Keywords

Colony forming units; Particles; Environmental parameters; Operating room; Surgical site infection

Outcome Measures

Primary Outcomes (2)

• Association of bacteria (CFU) and particles

  By measuring particles and CFU in proximity of each other, an association between the two units can be used to predict the CFU, based on the particle count.

  02/28/2022 - 06/31/2023

• Environmental parameters association with surgical site infections

  Environmental parameters (temperature, humidity, air pressure, door openings, persons present, particles) are being recorded into a database and cross referenced with patient registries to investigate the association with surgical site infections

  01/01/2021 - 12/31/2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects included in the study are patients who are getting either arthroplasty surgery or fixation with nails and/or plates due to fracture or arthritis. Patients who are going through a revision surgery are also included, with the exception of revision due to infection.

You may qualify if:

• Orthopedic implant related surgery
• Surgery in operating rooms with installed equipment

You may not qualify if:

• Non-implant related surgery
• No Swedish citizen (no personal-id number)
• Revision surgery due to infection

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Getinge Group: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maziar Mohaddes, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrik Malchau, PhD

CONTACT

708207651; hmalchau@mgh.harvard.edu

Frans Stålfelt, McS

CONTACT

0730317678; frans.stalfelt@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

SE (1)