Antimicrobial prophylaxis during Hirudo medicinalis therapy: a multicenter study
Kruer RM, Barton CA, Roberti G, Gilbert B, McMillian WD (2014) · Journal of Reconstructive Microsurgery · n=59
Study Profile
- Design
- multicenter retrospective cohort study of adult patients receiving medicinal leech therapy across multiple US academic centers (Johns Hopkins Hospital, Oregon Health & Science University, University of Florida Jacksonville, Fletcher Allen Health Care Vermont) from January 2010 through February 2013, evaluating antibiotic prophylaxis regimens and surgical site infection (SSI) outcomes
- Sample size (n)
- 59
- Intervention
- Documentation of prophylactic antibiotic regimens used during medicinal leech therapy across US centers: ciprofloxacin (61.1%), trimethoprim-sulfamethoxazole/SXT (33.3%), piperacillin-tazobactam (3.7%), and ceftriaxone (3.7%); 54 of 59 patients (91.5%) received documented prophylaxis
- Comparator
- Cross-regimen comparison of SSI incidence among the four documented prophylaxis agents; no randomized comparator
- Primary endpoint
- Incidence of post-MLT surgical site infection (SSI), with secondary evaluation of Aeromonas isolates and their susceptibility to the prophylactic agent administered
- Primary result
- 7 of 59 patients (11.9%) developed SSI, all of whom had received antibiotic prophylaxis; Aeromonas spp. isolated in 4 infections, and 100% of these isolates were resistant to the prophylactic agent administered to that patient; SSI incidence was statistically similar between ciprofloxacin and SXT cohorts, suggesting both agents are reasonable choices despite breakthrough infections
- Follow-up duration
- duration of hospitalization plus postoperative monitoring (variable by institution; up to 90 days for SSI surveillance)
- PMID
- 25423029
Key Findings
- Multicenter US documentation that both ciprofloxacin and trimethoprim-sulfamethoxazole are equally common and equally effective prophylactic choices
- 11.9% SSI incidence despite >90% prophylaxis coverage — breakthrough infections occur
- 100% of Aeromonas isolates from breakthrough infections were resistant to the patient's prophylactic agent, suggesting selection effects and the need for culture-driven adjustment
- Provides the strongest multi-center US benchmark for baseline SSI rate during K040187-cleared leech therapy
- Methodologically supports the institutional move toward dual-agent or culture-tailored prophylaxis regimens reported in later studies (Beka 2018, Wilmer 2013)
Limitations
- Retrospective design — antibiotic choice and culture timing not standardized across sites
- Modest sample (n=59) limits ability to detect rare adverse events or differences between specific regimens
- No randomization to prophylactic regimen — channeling bias likely (more comorbid patients may have received broader-spectrum agents)
- Limited indication detail — heterogeneous flap, replant, and reconstruction scenarios pooled together
- Susceptibility testing methodology varied by institutional laboratory practice
Clinical Implications
Kruer 2014 is the foundational multicenter US prophylaxis cohort during medicinal leech therapy and remains the most commonly cited reference for the dual-agent practice (ciprofloxacin or SXT as defensible first-line choices) in the K040187 protocol literature. For US clinicians, the trial supports either ciprofloxacin or trimethoprim-sulfamethoxazole as appropriate empiric prophylaxis while highlighting that no regimen prevents all breakthrough Aeromonas SSI — emphasizing the importance of vigilant clinical monitoring, prompt culture-based regimen adjustment, and institutional surveillance for emerging resistance patterns (as later documented by Beka 2018 and Wilmer 2013).
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