Sociedad Americana de Hirudoterapia

Management of complications and compromised free flaps following major head and neck surgery

Kucur C, Durmus K, Uysal IO, Old M, Agrawal A, Arshad H, Teknos TN, Ozer E (2015) · European Archives of Oto-Rhino-Laryngology · n=260

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 retrospective cohort study of 260 consecutive patients undergoing microvascular free-flap reconstruction following head and neck cancer extirpation at The Ohio State University Wexner Medical Center / Arthur G. James Cancer Hospital, July 2006 through June 2010
Sample size (n)
260
Intervention
Description of management strategies for compromised free flaps and major H&N reconstruction complications, including 11 patients (4.2%) treated with medicinal leech therapy for vascular congestion as part of the salvage protocol
Comparator
Within-cohort comparison of management approaches (hyperbaric oxygen therapy, leech therapy, repeat surgery, conservative wound care); no randomized comparator
Primary endpoint
Overall free flap survival rate and management outcomes of postoperative complications (vascular congestion, infection, dehiscence, hematoma, brisk bleeding, osteoradionecrosis, flap necrosis)
Primary result
96.5% overall flap survival across 260 cases (only 3.5% complete flap failure); among the 11 patients with vascular congestion treated with medicinal leech therapy, leech therapy was reported effective; in contrast, hyperbaric oxygen therapy was ineffective in 3 of 20 treated patients (all 3 progressed to complete flap loss); 44 of 78 complications required repeat surgery
Follow-up duration
duration of hospitalization plus institutional postoperative follow-up (median follow-up not specified)

Key Findings

  • Largest published US H&N free-flap series (n=260) documenting leech therapy as a routine component of salvage protocols (4.2% utilization)
  • Reported leech therapy as effective in all 11 patients with vascular congestion — counter-signal to selection-bias concerns
  • Adds Ohio State / Arthur G. James Cancer Hospital institutional experience to the K040187 evidence base
  • Documented 96.5% overall flap survival rate, with leech therapy contributing to salvage in the small congestion subset
  • Provides comparison context with hyperbaric oxygen therapy, which was ineffective in 3 of 20 treated patients

Limitations

  • Retrospective single-center design — selection bias and indication confounding likely
  • Small leech subset (n=11) - effectiveness reported descriptively without statistical comparison
  • No standardized leech protocol detail (number of leeches, duration, antibiotic prophylaxis) reported in abstract
  • Patient-reported outcomes and long-term cosmetic/functional results not described
  • Outcome adjudication by treating team — no independent assessor blinding

Clinical Implications

Kucur 2015 documents the routine institutional use of medicinal leech therapy for venous congestion of compromised head and neck free flaps in a high-volume US academic cancer center. The 4.2% utilization rate and reported effectiveness establish that leech therapy is a normative component of the K040187-cleared microsurgical salvage repertoire in US otolaryngology and plastic-surgery practice. For US clinicians, this trial complements the Whitaker 2011 UK series, Merlino 2020 European series, and Brennan 2020 low-volume Hawaii experience to give a multi-site picture of contemporary leech-therapy utilization in head and neck reconstruction.

Related Trials

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