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Effect of Ultraclean Air in Operating Rooms on Deep Sepsis in the Joint after Total Hip or Knee Replacement: a Randomised Study.

·BMJ·1982·695 citations·Hip & Knee
Free Full Text·DOI·PubMed
SummaryAbstract on PubMed →

Multicentre RCT across 19 hospitals randomizing over 8000 total hip and knee replacements between conventional ventilation and ultraclean-air OR systems. Asks whether reducing airborne bacterial contamination reduces confirmed deep joint sepsis requiring reoperation. Some centers also tested whole-body exhaust-ventilated suits and evaluated antibiotic prophylaxis as an independent variable.

Study Snapshot

Design
Multicenter RCT
Blinding: Open-label
Setting: 19 hospitals, England, Scotland, Sweden
Funding: MRC and DHSS
Objective
Determine whether ultraclean air reduces deep infection after total hip or knee replacement
Outcome(s)
Deep joint sepsis confirmed at reoperation within 1–4 years
Subjects
8055 total hip/knee replacements across 19 hospitals
  • 4133Conventional ventilation, standard clothing — control
  • 1789Ultraclean air, conventional clothing
  • 2133Ultraclean air, body-exhaust suits or isolator
Inclusion
  • Total hip or knee replacement
  • Surgeon operated in both control and ultraclean rooms
Exclusion
  • Protocol non-compliance (n=45)
  • Missing essential data (n=36)
Follow-up
1–4 years (median ~2.5 years)
Statistics
Chi-square / ratio analysis95% confidence intervals

Key Findings

  • Ultraclean air cut confirmed deep joint sepsis from 1.5% to 0.6% — a 2.6-fold reduction across all 19 hospitals (95% CI 1.6–4.2, p<0.001).
  • Adding whole-body exhaust-ventilated suits to ultraclean air amplified the benefit to a 4.5-fold reduction (0.3% vs 1.3%, 95% CI 1.8–11.0, p<0.001), while ultraclean air alone without special suits achieved only a 2.0-fold reduction.
  • Antibiotic prophylaxis independently cut sepsis fourfold: 2.3% without antibiotics vs 0.6% with (ratio 4.0, 95% CI 2.6–6.2, p<0.001). And the effect held across both conventional and ultraclean-air conditions.
  • The authors estimate ultraclean air and antibiotics together produce an ~eightfold combined reduction, consistent with independent, additive mechanisms. This is the rationale behind modern multilayer infection prevention protocols.
  • Staph aureus caused 33% of confirmed sepsis cases; significant pathogens were recovered at reoperation in 81% of infected joints. And when sepsis drove the revision, a replacement prosthesis was reimplanted in fewer than half of cases vs over 90% in non-septic revisions.
Board PearlUltraclean OR air halves deep joint sepsis after arthroplasty; adding body-exhaust suits and antibiotics achieves an estimated eightfold combined reduction.

Clinical Relevance

Before this paper, sepsis rates after joint replacement reached 10% at some centers, and debate persisted for over a century about whether OR air quality actually mattered clinically. This trial settled that question: both ultraclean air and antibiotic prophylaxis independently reduce deep joint infection, and each layer of protection adds to the last.

When you scrub in for a primary THA or TKA, the laminar flow overhead, the prophylactic cefazolin you ordered preoperatively, and the surgical attire your team wears are all traceable to the framework this paper established — each cuts infection risk, and together they multiply the benefit.

The outcome data carry a practical warning: septic failures result in prosthesis reimplantation less than half the time, compared to over 90% for aseptic failures. Getting infection prevention right the first time is not just about avoiding morbidity. It is about preserving reconstructive options.

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|

Effect of Ultraclean Air in Operating Rooms on Deep Sepsis in the Joint after Total Hip or Knee Replacement: a Randomised Study.

·BMJ·1982·695 citations·Hip & Knee
Free Full Text·DOI·PubMed
SummaryAbstract on PubMed →

Multicentre RCT across 19 hospitals randomizing over 8000 total hip and knee replacements between conventional ventilation and ultraclean-air OR systems. Asks whether reducing airborne bacterial contamination reduces confirmed deep joint sepsis requiring reoperation. Some centers also tested whole-body exhaust-ventilated suits and evaluated antibiotic prophylaxis as an independent variable.

Study Snapshot

Design
Multicenter RCT
Blinding: Open-label
Setting: 19 hospitals, England, Scotland, Sweden
Funding: MRC and DHSS
Objective
Determine whether ultraclean air reduces deep infection after total hip or knee replacement
Outcome(s)
Deep joint sepsis confirmed at reoperation within 1–4 years
Subjects
8055 total hip/knee replacements across 19 hospitals
  • 4133Conventional ventilation, standard clothing — control
  • 1789Ultraclean air, conventional clothing
  • 2133Ultraclean air, body-exhaust suits or isolator
Inclusion
  • Total hip or knee replacement
  • Surgeon operated in both control and ultraclean rooms
Exclusion
  • Protocol non-compliance (n=45)
  • Missing essential data (n=36)
Follow-up
1–4 years (median ~2.5 years)
Statistics
Chi-square / ratio analysis95% confidence intervals

Key Findings

  • Ultraclean air cut confirmed deep joint sepsis from 1.5% to 0.6% — a 2.6-fold reduction across all 19 hospitals (95% CI 1.6–4.2, p<0.001).
  • Adding whole-body exhaust-ventilated suits to ultraclean air amplified the benefit to a 4.5-fold reduction (0.3% vs 1.3%, 95% CI 1.8–11.0, p<0.001), while ultraclean air alone without special suits achieved only a 2.0-fold reduction.
  • Antibiotic prophylaxis independently cut sepsis fourfold: 2.3% without antibiotics vs 0.6% with (ratio 4.0, 95% CI 2.6–6.2, p<0.001). And the effect held across both conventional and ultraclean-air conditions.
  • The authors estimate ultraclean air and antibiotics together produce an ~eightfold combined reduction, consistent with independent, additive mechanisms. This is the rationale behind modern multilayer infection prevention protocols.
  • Staph aureus caused 33% of confirmed sepsis cases; significant pathogens were recovered at reoperation in 81% of infected joints. And when sepsis drove the revision, a replacement prosthesis was reimplanted in fewer than half of cases vs over 90% in non-septic revisions.
Board PearlUltraclean OR air halves deep joint sepsis after arthroplasty; adding body-exhaust suits and antibiotics achieves an estimated eightfold combined reduction.

Clinical Relevance

Before this paper, sepsis rates after joint replacement reached 10% at some centers, and debate persisted for over a century about whether OR air quality actually mattered clinically. This trial settled that question: both ultraclean air and antibiotic prophylaxis independently reduce deep joint infection, and each layer of protection adds to the last.

When you scrub in for a primary THA or TKA, the laminar flow overhead, the prophylactic cefazolin you ordered preoperatively, and the surgical attire your team wears are all traceable to the framework this paper established — each cuts infection risk, and together they multiply the benefit.

The outcome data carry a practical warning: septic failures result in prosthesis reimplantation less than half the time, compared to over 90% for aseptic failures. Getting infection prevention right the first time is not just about avoiding morbidity. It is about preserving reconstructive options.

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