Bacterial Air Contamination

NCT05597072 | Unknown

• 1 other identifier: BAirCon 2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Aim is to compare the effect of number of persons and time-dependant bacterial air contamination on sterile goods, using different preparation conditions and protective sterile covers. Research questions Is there a difference in bacterial air contamination during preparation of the sterile surgical goods with 2 persons (intervention) compared with 4-5 persons (control) in the OR? Is there a time-dependent difference in bacterial air contamination pending surgery for 1 hour (control) compared to approximately 12 hours (intervention) when the sterile goods are protected with sterile covers? Is there a time-dependent difference in bacterial air contamination pending surgery if sterile goods are protected or not, by sterile covers? Is there any differences in surgical site infections between the groups? What type of bacteria contain the air contamination? Is there antibiotic resistant bacterial air contamination?

Conditions

Infection Control

Keywords

Infection control

Outcome Measures

Primary Outcomes (1)

• Colony forming units

  Bacterial growth

  from one to 15 hours

Study Arms (2)

Intervention

EXPERIMENTAL

In the evening before an elective surgery the sterile surgical goods will be prepared under calm circumstances with only 2 persons in the OR (intervention). Thereafter, the sterile goods will be protected with sterile covers and time pending surgery will be approximately 12 hours (intervention).

Behavioral: Intervention

Control

ACTIVE COMPARATOR

The control is to prepare the sterile goods in the morning with more people in the OR (approximately 4-5 persons).

Behavioral: Control

Interventions

Intervention BEHAVIORAL

Less people within the OR but longer waiting time.

Intervention

Control BEHAVIORAL

More people in the OR but shorter waiting time

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients where partial thoracotomy or endovascular procedures are performed. Patients with infection and procedures as infective endocarditis. No research nurse available.

Sponsors & Collaborators

• Camilla Wistrand: lead

Study Sites (1)

University Hospital

Örebro, 70185, Sweden

RECRUITING

Related Publications (2)

• Wistrand C, Soderquist B, Sundqvist AS. The effect of five versus two personnel on bacterial air contamination during preparation of sterile surgical goods in the operating room: a randomised controlled trial. Antimicrob Resist Infect Control. 2025 Jun 15;14(1):68. doi: 10.1186/s13756-025-01589-4.

  PMID: 40518530 DERIVED

• Wistrand C, Soderquist B, Friberg O, Sundqvist AS. Bacterial air contamination and the protective effect of coverage for sterile surgical goods: A randomized controlled trial. Am J Infect Control. 2025 Apr;53(4):467-472. doi: 10.1016/j.ajic.2024.12.012. Epub 2024 Dec 16.

  PMID: 39694445 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Camilla Wistrand, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Wistrand, PhD

CONTACT

+46707686938; camilla.wistrand@regionorebrolan.se

Ann-Sofie Sundqvist, PhD

CONTACT

ann-sofie.sundqvist@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University Hospital in Örebro

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: May 17, 2022
• Primary Completion: November 30, 2023
• Study Completion: May 31, 2024
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)