American Society of Hirudotherapy

Comparisons of medicinal leech therapy with venous catheterization in the treatment of venous congestion of the sural flap

Mozafari N, Ghazisaidi MR, Hosseini SN, Abdolzadeh M (2010) · Microsurgery · n=56

RCT evidence detailTrial reference
GRADE LowCohort / case series
Sample size of this trial compared with other venous-congestion-flap trialsMarquard JM 20251215Bishop JL 2023843Doğan S 2024570Troeltzsch M 2016330Kucur C 2015260Wang ZD 2022210Lehnhardt M 202196Kruer RM 201459Mozafari N 201056Merlino G 202048
This trial (highlighted) by sample size alongside other indexed venous-congestion-flap trials. Larger trials generally carry more statistical weight.

Study Profile

Design
single-center, open-label, randomized controlled trial comparing medicinal leech therapy with venous catheterization for venous congestion of the distally based sural flap (Shahid Beheshti University of Medical Sciences, Tehran, Iran)
Sample size (n)
56
Intervention
Medicinal leech therapy (MLT) for venous congestion of conventional distally based sural flaps (n=28); Hirudo medicinalis applied to the congested flap until adequate venous drainage achieved
Comparator
Venous catheterization (VC) with local heparin irrigation as alternative method of acute blood-volume removal (n=28)
Primary endpoint
Average volume of removed blood, infection rate, wound dehiscence, flap necrosis, and patient/nursing satisfaction
Primary result
Average blood volume removed: 172.2 cc (MLT) vs 53.6 cc (VC); infection 34.6% (MLT) vs 10.7% (VC); wound dehiscence 42.3% (MLT) vs 10.7% (VC); flap necrosis 19.2% (MLT) vs 3.6% (VC); nursing satisfaction 5.19 (MLT) vs 7.8 (VC); patient satisfaction 5.6 (MLT) vs 8.03 (VC). Authors recommended VC over leech therapy for congested pedicled flaps
Follow-up duration
until full flap survival or necrosis resolution
PMID
21207496

Key Findings

  • Rare cautionary RCT favoring venous catheterization over MLT for sural-flap venous congestion in an Iranian academic plastic surgery center
  • Higher infection, dehiscence, and flap necrosis rates in the MLT arm versus venous catheterization
  • Catheter exchange was needed in 10 patients due to clot obstruction despite local heparin irrigation - VC arm not without operational burden
  • Nursing satisfaction and patient satisfaction both favored the catheter arm
  • Important counterweight to the optimistic Merlino 2020 and Lehnhardt 2021 microsurgical-flap leech RCTs - shows that flap-type, surgeon experience, and operational context strongly modify the leech-vs-alternative comparison

Limitations

  • Single Iranian center - results may not generalize to high-volume Western microsurgery centers with established leech protocols
  • Open-label - allocation known to surgeons, who controlled both the technical execution and outcome adjudication
  • Pedicled sural flap is a different surgical context than free flap (where Merlino 2020 and Lehnhardt 2021 found leech superiority)
  • Infection rates much higher than reported in German RCTs - possible local antimicrobial-stewardship or culture-handling differences
  • Heparin irrigation protocol may not represent global best practice for VC alternative

Clinical Implications

Mozafari 2010 is an important cautionary RCT that should be cited alongside Merlino 2020 and Lehnhardt 2021 to give clinicians a balanced view. The data suggest that for pedicled sural flap venous congestion, MLT may not be superior - and may be inferior - to venous catheterization with heparin irrigation. The discrepancy with the European free-flap literature likely reflects flap-type (pedicled vs free), operational context, and team experience. For US clinicians, the trial supports careful patient-selection and surgical-context evaluation before defaulting to leech therapy in flap salvage. The trial does not invalidate leech therapy for free-flap venous congestion but does highlight that 'leech therapy for venous congestion' is not a monolithic indication.

Related Trials

Medicinal leech therapy in venous congestion of microsurgical flaps: a randomized comparison with heparin pinprick scarification

Merlino G, Carbone S, Servillo G, Marletta DA (2020)

Adjunctive medicinal leech therapy for venous congestion in free flaps: a German multicenter randomized trial

Lehnhardt M, Daigeler A, Behr B, Schmidt SV, Wallner C (2021)

Medicinal leeches and the microsurgeon: a four-year study, clinical series and risk benefit review

Whitaker IS, Josty IC, Hawkins S, Azzopardi E, Naderi N, Graf J, Damaris L, Lineaweaver WC, Kon M (2011)

Medicinal leeches for surgically uncorrectable venous congestion after free flap breast reconstruction

Pannucci CJ, Nelson JA, Chung CU, Fischer JP, Kanchwala SK, Kovach SJ, Serletti JM, Wu LC (2014)

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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.