Bacterial Contamination of Operative Splash Basins
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2015 |
| End Date: | February 2016 |
Bacterial Contamination of Operative Splash Basins: Can it be Prevented?
The primary objective of this study is to compare the efficacy of adding 0.05% chlorhexidine
gluconate to the splash basin in reducing bacterial growth from splash basins at the end of
a total joint replacement procedure.
Hypothesis: The 0.05% chlorhexidine gluconate solution will reduce the bacterial growth at
the end of elective total joint arthroplasty cases.
Null Hypothesis: There will be no difference in bacterial growth from the splash basin at
the end of the case despite the addition of an antimicrobial solution.
gluconate to the splash basin in reducing bacterial growth from splash basins at the end of
a total joint replacement procedure.
Hypothesis: The 0.05% chlorhexidine gluconate solution will reduce the bacterial growth at
the end of elective total joint arthroplasty cases.
Null Hypothesis: There will be no difference in bacterial growth from the splash basin at
the end of the case despite the addition of an antimicrobial solution.
Total joint arthroplasty of the hip and knee is a procedure growing substantially in number
in the United States. Projections approach 2 million combined total hip and total knee
arthroplasty procedures by the year 2021[1, 2]. With the incidence of post-arthroplasty
infection ranging from 1-2% of primaries and 3-5% of revisions, the number of cases of
periprosthetic infection will be significant[1, 3-7]. The associated economic burden is
projected to exceed $1.62 billion[2]. With these numbers in mind it is our responsibility in
the orthopaedic community to do what we can to reduce the social and economic impact that
this devastating complication creates.
While all surgical procedures carry the risk of bacterial contamination, those that implant
prosthetic material are particularly high risk for future problems due to the development of
biofilms and difficulty eradicating such infections. The most common time of inoculation of
the implant is at the time of surgery. Whyte et al.[8] showed that the source of infection
was the operating room personnel in 98% of cases while only 2% of the time it was the
patient's own skin. The transfer of contaminants occurred via direct transfer through the
hands or instruments 70% of the time. Knobben et al.[9] reported transfer of bacteria
between biomaterial surfaces at a rate of 17%-71% demonstrating the ability of bacteria to
spread to all types of materials in the operative field. The direct contact of these
surfaces with the patient or prosthetic implant makes early contamination during surgery a
likely cause of periprosthetic infection. Maathuis et al.[10] suggested that at least 30% of
patients leave the operating suite with bacterial contamination.
The splash basin has been used for many years in the operating room as a place to wash
instruments and clean them of debris for potential re-use during the surgical case. This
often places multiple instruments within the bath of washings or in direct contact with
previously used tools. Several studies have shown evidence of bacterial contamination of
these basins[11-14]. Rates of 2.17% to 74% of contamination of the splash basin have been
reported. In a study by Anto et al.[11] an average of 45.7 instruments were placed in the
splash basin per case. The opportunity for bacteria to be transferred to the surgical wound
upon re-use of an instrument from the basin is therefore concerning.
Given that the splash basin is a potential source of surgical wound contamination we have
sought to eliminate the bacterial colonization of this source through the addition of an
antimicrobial solution to the normal sterile water bath. To compare potential interventions,
a prospective study comparing a 0.05% chlorhexidine gluconate (CHG) antimicrobial solution
to the current standard of sterile water as a control is proposed. This concentration of CHG
followed by a saline rinse has been shown to decrease the risk of infection during wound
irrigation without increasing the risk of adverse effects[15, 16].
Given our expertise in the area of total joint arthroplasty and experience with treating
periprosthetic infections as well as familiarity with various antimicrobial solutions we
feel well qualified to perform this study. The results of this study could improve patient
outcomes by potentially eliminating a source of infection in the operating room.
in the United States. Projections approach 2 million combined total hip and total knee
arthroplasty procedures by the year 2021[1, 2]. With the incidence of post-arthroplasty
infection ranging from 1-2% of primaries and 3-5% of revisions, the number of cases of
periprosthetic infection will be significant[1, 3-7]. The associated economic burden is
projected to exceed $1.62 billion[2]. With these numbers in mind it is our responsibility in
the orthopaedic community to do what we can to reduce the social and economic impact that
this devastating complication creates.
While all surgical procedures carry the risk of bacterial contamination, those that implant
prosthetic material are particularly high risk for future problems due to the development of
biofilms and difficulty eradicating such infections. The most common time of inoculation of
the implant is at the time of surgery. Whyte et al.[8] showed that the source of infection
was the operating room personnel in 98% of cases while only 2% of the time it was the
patient's own skin. The transfer of contaminants occurred via direct transfer through the
hands or instruments 70% of the time. Knobben et al.[9] reported transfer of bacteria
between biomaterial surfaces at a rate of 17%-71% demonstrating the ability of bacteria to
spread to all types of materials in the operative field. The direct contact of these
surfaces with the patient or prosthetic implant makes early contamination during surgery a
likely cause of periprosthetic infection. Maathuis et al.[10] suggested that at least 30% of
patients leave the operating suite with bacterial contamination.
The splash basin has been used for many years in the operating room as a place to wash
instruments and clean them of debris for potential re-use during the surgical case. This
often places multiple instruments within the bath of washings or in direct contact with
previously used tools. Several studies have shown evidence of bacterial contamination of
these basins[11-14]. Rates of 2.17% to 74% of contamination of the splash basin have been
reported. In a study by Anto et al.[11] an average of 45.7 instruments were placed in the
splash basin per case. The opportunity for bacteria to be transferred to the surgical wound
upon re-use of an instrument from the basin is therefore concerning.
Given that the splash basin is a potential source of surgical wound contamination we have
sought to eliminate the bacterial colonization of this source through the addition of an
antimicrobial solution to the normal sterile water bath. To compare potential interventions,
a prospective study comparing a 0.05% chlorhexidine gluconate (CHG) antimicrobial solution
to the current standard of sterile water as a control is proposed. This concentration of CHG
followed by a saline rinse has been shown to decrease the risk of infection during wound
irrigation without increasing the risk of adverse effects[15, 16].
Given our expertise in the area of total joint arthroplasty and experience with treating
periprosthetic infections as well as familiarity with various antimicrobial solutions we
feel well qualified to perform this study. The results of this study could improve patient
outcomes by potentially eliminating a source of infection in the operating room.
Inclusion Criteria:
- Splash Basins will be selected from primary total joint arthroplasty cases and then
randomized to a solution of either sterile water or sterile water with 0.05% CHG.
- Other than being scheduled for a primary total joint arthroplasty, the participant
information will not be reviewed for selection of the splash basin, but will be
collected for comparison of patient characteristics and potentially for future
reference to compare infection rates in patients associated with this study.
Exclusion Criteria:
- Splash basin used in a revision total joint procedure
- Splash basin used in cases where the patient has a history of known periprosthetic
joint infection
- Splash basin used in cases where the patient has a known allergy to chlorhexidine
gluconate
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