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Do face shields and surgical masks provide the same protection as surgical space suits against infection during joint replacement surgery?

Comparative efficacy of standard surgical mask with face shield versus surgical space suits in reducing surgeon facial contamination and surgical site infection during Arthroplasty-A randomized controlled trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/096782
Enrollment
2000
Registered
2025-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: Arm 2: Surgeons wearing standard surgical mask with face shield during total joint arthroplasty. Duration-2 years Control Intervention1: Arm 1: Surgeons using surgical space suit system

Sponsors

Fortis Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective total knee arthroplasty

Exclusion criteria

Exclusion criteria: Revision arthroplasty, septic revision, or surgery for known or suspected periprosthetic joint infection. Additional procedures performed simultaneously that substantially prolong operative time or increase contamination risk Patients unable to complete the minimum follow-up period (90 days) or unwilling to participate

Design outcomes

Primary

MeasureTime frame
Airborne particle count measured using handheld particle counter intra operativelyTimepoint: at rest before incision during bone cuts after component implantation—

Secondary

MeasureTime frame
length of the procedure the number of people present in the theatre the door-opening rate per procedure the duration of use of instruments that produce surgical smoke. Surgical site Infection upTimepoint: Intraoperatively & at 90 days only for surgical site infection—

Countries

India

Contacts

Public ContactDrJesmick Ponniah k

Fortis Hospital

drnhulse@gmail.com9591382501

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026