American Society of Hirudotherapy

Safety Framework

Medicinal leech therapy has a relatively favorable safety profile when appropriate protocols are followed. Key risks include infection (1.3-9.7%), prolonged bleeding (median duration 24-72 hours), and rare allergic reactions. Systematic protocols are essential for risk mitigation.

1. Patient Selection Criteria

1.1 Inclusion Criteria

Venous Congestion:/ Tissue congestion from venous insufficiency, replantation surgery, or trauma
Failed Conventional Therapy:/ Patients who have not responded to standard treatments
Informed Consent:/ Patient understands risks (infection, bleeding, scarring) and benefits
Adequate Support: Ability to monitor and manage post-treatment bleeding (24-72 hours)

1.2 Absolute Contraindications

Coagulopathy:/ Hemophilia, von Willebrand disease, or other bleeding disorders
Anticoagulation: Current use of warfarin, heparin, or DOACs (must be discontinued before treatment)
Septicemia: Active systemic infection
Severe Anemia: Hemoglobin < 8 g/dL without transfusion support
Immunocompromise: AIDS, active chemotherapy, or immunosuppressive therapy (without adequate antibiotic prophylaxis)

1.3 Relative Contraindications

Aspirin/NSAIDs: Increased bleeding duration (discuss withholding 7-10 days)
Diabetes:/ Increased infection risk (requires prophylactic antibiotics)
Pregnancy: Inadequate safety data (avoid unless no alternatives)
Pediatric Patients: Limited evidence; requires close monitoring

2. Infection Control

2.1 Aeromonas Infection Risk

Aeromonas spp. are commensal bacteria in the leech digestive tract that can rarely cause infection (1.3-9.7% incidence). Most infections are mild and localized; severe disseminated infections are extremely rare.

2.2 Antibiotic Protocols

Prophylactic Regimens

First-Line Prophylaxis:

Ciprofloxacin: 500 mg PO BID for 7-14 days
Trimethoprim-sulfamethoxazle: 800/160 mg PO BID for 7-14 days

Alternative Regimens:

Amoxicillin-clavulanate: 875/125 mg PO BID
Doxycycline: 100 mg PO BID
Levofloxacin: 500 mg PO QD

Important: Aeromonas is inherently resistant to cephalosporins, penicillin, macrolides, and vancomycin. Do not use these agents for prophylaxis.

2.3 Infection Monitoring

Clinical Signs: Monitor for erythema, warmth, swelling, purulent drainage, or foul odor (48-96 hours post-treatment)
Systemic Signs: Fever, chills, leukocytosis (if present, check WBC)
Early Intervention: If infection suspected, obtain wound culture and start empiric antibiotics immediately

3. Bleeding Management

3.1 Expected Bleeding

Post-leech bleeding is expected and normal due to anticoagulant salivary compounds. Typical bleeding duration: 24-72 hours (median 48 hours). Patients should be counseled that this is part of the therapeutic process.

3.2 Patient Education

Pre-Treatment Counseling

Bleeding is expected and will last 24-72 hours
Expect to use 10-15 absorbent pads per 24 hours
Avoid vigorous activity, heavy lifting, or straining
Keep affected area elevated when possible
Seek care if bleeding is excessive or if signs of infection develop

3.3 Bleeding Control Techniques

Stepwise Approach

First-Line (Routine):
- Apply absorbent dressings (change every 4-8 hours)
- Elevate affected area
- Avoid disrupting clot formation
Second-Line (Persistent Bleeding):
- Thrombin powder or gelatin sponge
- Pressure dressing (avoid excessive pressure)
- Silver nitrate stick (cautiously; can cause tissue damage)
Third-Line (Refractory Bleeding):
- Topical hemostatic agents (FlowSeal AH, SurgiCel)
- Suture ligation (ultimate resort)
- Consider transfusion if hemoglobin drops significantly

Warning: Never use direct pressure or cautery as first-line treatment. This can trigger heavy bleeding and tissue damage. Allow normal bleeding to proceed with absorbent dressings.

4. Adverse Event Management

4.1 Common Adverse Events

Local Reactions

Pain/Discomfort: Typically mild; manage with acetaminophen
Erythema/Edema: Expected; resolves in 48-72 hours
Scarring: Minimal if proper technique used
Itching: Topical antihistamines; avoid scratching

Systemic Reactions

Allergic Reactions: Rare; treat per standard protocols
Anemia: Monitor CBC if heavy bleeding
Infection: See Section 2 (above)
Vasovagal Response: Extremely rare; supportive care

4.2 Emergency Management

Seek Immediate Care If:

Uncontrolled bleeding despite conservative measures
Signs of hemorrhagic shock (hypotension, tachycardia, altered mentation)
Sevure allergic reaction (anaphylaxis)
Signs of systemic infection (fever, rigors, hypotension)
Severe anemia (Hb < 7 g/dL)

5. Institutional Implementation

5.1 Protocol Development

Institutions should develop written protocols covering patient selection, treatment procedures, post-procedure care, and complication management. Protocols should be:

Evidence-based and regularly updated
Approved by institutional review board (IRB) or pharmacy & therapeutics committee
Accessible to all staff involved in leech therapy
Regularly audited for compliance

5.2 Staff Training

All personnel involved in leech therapy should receive training on:

Leech biology and mechanism of action
Application techniques and best practices
Patient selection criteria and contraindications
Infection control and antibiotic protocols
Bleeding management and patient education
Emergency protocols and when to escalate care

5.3 Quality Assurance

Track Outcomes: Maintain registry of all leech therapy cases
Monitor Complications: Track infection and bleeding rates
Regular Review:/ Periodic audit of protocol adherence
Continuous Improvement: Update protocols based on new evidence

Clinical Bottom Line

Medicinal leech therapy can be safely administered when proper safety protocols are followed. Key elements include: (1) careful patient selection and screening for contraindications, (2) routine prophylactic antibiotics (ciprofloxacin or TMP-1M[L[), (3) patient education on expected bleeding and warning signs, (4) systematic bleeding management algorithms, and (5) institutional protocols with staff training and quality assurance monitoring.

Safety Protocols