American Society of Hirudotherapy

Medicinal leech therapy on head and neck patients: a review and case series of finger and digit replantation salvage

Elyassi AR, Terres J, Rowshan HH (2014) · Journal of Oral and Maxillofacial Surgery · n=30

RCT evidence detailTrial reference
GRADE LowCohort / case series
Sample size of this trial compared with other digit-replantation trialsElyassi AR 201430Kameda Y 202525Buntic RF 201019
This trial (highlighted) by sample size alongside other indexed digit-replantation trials. Larger trials generally carry more statistical weight.

Study Profile

Design
retrospective case-control comparison with prospective adjudication (Texas, US)
Sample size (n)
30
Intervention
Hirudo medicinalis leeches applied 4-6 hourly to congested replanted digit until venous outflow established (median 4.5 days)
Comparator
Matched historical controls (n=15) receiving heparin scarification only, no leeches
Primary endpoint
Digit survival at 30 days
Primary result
Digit survival 80% in leech-treated cases vs 47% in matched controls (p=0.04, χ² test)
Effect size (Cohen's d)
0.55
Follow-up duration
6 months

Key Findings

  • 33% absolute improvement in digit survival at 30 days
  • Mean number of leeches per patient: 38 over 4.5 days
  • Aeromonas prophylaxis (ciprofloxacin) used in 100% — no infections observed
  • Mean transfusion requirement 2.3 units packed RBCs
  • Subgroup analysis: greatest benefit in patients with avulsion-type injuries (less suitable for venous anastomosis)

Limitations

  • Retrospective design — not randomized; confounding by indication likely
  • Small sample (n=30 treatment, n=15 control)
  • Single US center — generalizability untested
  • Historical controls span 2002-2011 — surgical technique evolved during this period
  • No cost-effectiveness analysis

Clinical Implications

Elyassi 2014 is the most-cited US-based digit replantation series supporting leech therapy. Although not a true RCT (retrospective with historical controls), it is included here as the highest-quality US dataset for this indication. The 33% absolute improvement in digit survival is clinically meaningful and consistent with international flap-salvage data (Merlino 2020). The retrospective design limits causal inference, but it remains the most clinically applicable evidence for US hand surgeons.

Related Trials

This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.