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January 12th, 2015

New CDC draft guidelines on surgical site infections find answers elusive to some complex questions

The Centers for Disease Control and Prevention has posted draft updated guidelines https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-01674.pdf for preventing surgical site infections, focusing on some difficult issues in an exhaustive and largely futile attempt to find conclusive data on various practices.

As a result, “no recommendation” is a recurrent theme in the document, though no page was apparently left unturned in the 261 references. Kudos to the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC), which like Diogenes looking for an honest man, scoured the evidence and largely came up wanting.

For example, here is the section on the question of wearing “orthopaedic space suits” for joint replacement procedures. The references are available in the CDC guideline, but were not reprinted for this excerpt.

“How safe and effective are orthopaedic space suits in reducing the risk of SSI in prosthetic joint arthroplasty patients, and which healthcare personnel should wear them?

“The available data evaluated the use of a space suit as compared to no space suit.

For this comparison we considered deep SSI requiring reoperation, deep SSI requiring revision, and deep SSI as the critical outcomes. Superficial SSI outcome was also evaluated. The evidence for this question consists of 3 OBS studies at low risk of bias. …

Very-low quality evidence suggested no benefit to using an orthopaedic space suit to reduce the risk of SSI. This was based on no difference in deep SSI requiring reoperation, deep SSI requiring revision surgery, or deep or superficial SSI in 3 OBS studies. The number of events for each of these studies was low. The largest national joint registry study with multiple subgroup analyses suggested that use of a space suit was associated with an increased number of deep SSIs requiring revision surgery within 6 months of THA or TKA, but this evidence was limited in size. Results did not differ based on the presence or absence of laminar flow. A large multicenter study using administrative data from patients undergoing TKA suggested no difference in deep SSIs requiring reoperation within 90 days. Reoperations included incision and drainage and implant removal. The definition of deep SSI in this study may have included PJI. Space suit and laminar flow use varied between groups. A third small study in THA and hip hemiarthroplasties reported only 1 deep SSI in the space suit group and 1 superficial SSI in each group at 24 months of follow up. High-efficiency particulate air (HEPA)/mixed turbulent filtration was used in both groups.

Our search did not identify data that quantified potential complications associated with the use of space suits. In one large national joint registry study (N=88,311) comments by surgeons completing a questionnaire (n=35) included “limited spatial awareness and ease of contamination due to an apparent false sense of security” with the use of a space suit.169 We did not evaluate the efficacy of the space suit as personal protective equipment.

Also, our search did not identify data that evaluated the association between specific health care personnel wearing a space suit and SSI. One retrospective controlled study included a surgeon questionnaire reporting that the surgeon, assistant, and scrub nurse were the team members wearing a full space suit. One prospective controlled study reported those same team members wearing the space suit in the intervention group.” Recommendation: No recommendation can be made regarding the safety and effectiveness of orthopaedic space suits or the health care personnel who should wear them for the prevention of surgical site infection in prosthetic joint arthroplasty. (No recommendation/unresolved issue)