Assessment of condoms for probe preparation method for ultrasound-guided musculoskeletal injections: a prospective, randomized non-inferiority trial

Assessment of condoms for probe preparation method for ultrasound-guided musculoskeletal injections: a prospective, randomized non-inferiority trial

The method of constructing a barrier using a probe cover is an effective way to reduce the chance of infection. Condoms are already widely in use as probe covers in endocavity procedures. The purpose of this study was to evaluate the safety of probe preparation using a condom by comparing culture results between the use of sterile probe covers and condoms, respectively, during ultrasound-guided musculoskeletal (MSK) injection procedures. A total of 152 participants were enrolled for this prospective non-inferiority trial (sterile probe cover group, n=76; condom group, n=76). The swab for culture was performed from the probe cover wrapped over the scanner site and the skin site of injection. Costs related to disinfection and image quality scores were also compared between the two groups. At the probe scanner site, the culture-positive rate was 1.3% in the sterile probe group and 0.0% in the condom group. Since the 95% confidence interval (-3.9% to 1.3%; mean difference: 1.3%) of the culture-positive rate of the condom group did not cross the non-inferiority delta of 2%, the non-inferiority of the condom group could be established. Also, the cost was significantly higher in the sterile probe cover group, and there was no significant difference in the subjective image quality score between the two groups. This study demonstrated the non-inferiority of condom use as compared with commercial sterile probe cover use. Our results would help in establishing a guideline for appropriate probe decontamination methods when conducting ultrasound-guided MSK injections.