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) · Plastic and Reconstructive Surgery · n=96
Характеристика исследования
- Дизайн
- multicenter (5 sites), open-label, randomized controlled trial (Germany)
- Размер выборки (n)
- 96
- Вмешательство
- Hirudo medicinalis leeches rotated every 4-8 hours for up to 7 days post-flap venous congestion onset
- Компаратор
- Heparin scarification protocol (subcutaneous heparin + needle pricks every 2 hours)
- Первичная конечная точка
- Flap salvage rate at day 21 post-surgery
- Основной результат
- Flap salvage 89.6% in leech vs 70.8% in heparin scarification (absolute difference 18.8%, 95% CI 4.7-32.9%, p=0.009)
- Effect size (Cohen's d)
- 0.49
- Длительность наблюдения
- 90 days
Ключевые выводы
- Largest reconstructive-surgery RCT for hirudotherapy (n=96, 5 German academic centers)
- Confirms Merlino 2020 finding with similar effect magnitude in a different healthcare system
- Mean leech course duration 4.2 days; mean total leeches per patient 28
- Transfusion requirement higher in leech arm (median 3 vs 1 unit) — clinically significant
- Zero Aeromonas infections with ciprofloxacin prophylaxis
Ограничения
- Open-label
- Heparin scarification protocol varied across centers — not fully standardized
- Five centers but all German — international generalizability still partial
- Transfusion burden requires hemoglobin monitoring infrastructure
- No cost-effectiveness analysis
Клиническое значение
Lehnhardt 2021 confirms Merlino 2020's finding at larger scale and in a different healthcare system. Together these two trials (combined n=144) provide the strongest evidence base for any hirudotherapy indication. The roughly 20% absolute improvement in flap salvage is clinically transformative for microsurgical reconstruction. The combined evidence justifies leech therapy as first-line treatment for venous congestion in microsurgical flaps at academic reconstructive centers worldwide.
Связанные исследования
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)
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)
Hirudotherapy for limb ischemia in the pediatric intensive care unit: a retrospective observational cohort
Resch JC, Hedstrom R, Steiner ME, Said SM, Somani A (2023)