Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years (AMLEE)

Venous congestion in transplanted or re-implanted tissues remains a common and chal-lenging complication in plastic and reconstructive surgery. Local application of medicinal leeches is effective to reduce postoperative venous congestion of the flap and to restore normal blood flow. However, leech therapy is associated with a number of risks, including infections. Indeed, leeches maintain a symbiotic relationship with Aeromonas species in order to digest blood in their gut. Aeromonas spp. infections can occur 1 to 30 days post-application of leeches and are associated with a dramatic decrease in flap salvage rates (88 to 30%). For these reasons, prophylactic antibiotics and, external decontamination are widely recommended throughout the course of leech therapy.

The aim of this study is to investigate the prevalence of side effects (anemia and infection) from patients treated with leeches in French Hospital.

Study Overview

• Status: Completed
• Conditions: Healthcare Associated Infection; Leeches
• Intervention / Treatment: Other: Leech Therapy

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)

Description

Inclusion Criteria:

• Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)

Exclusion Criteria:

• Hirudotherapy outside the inclusion period
• Hirudotherapy or less than 2 days of treatment

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aeromonas infection	Other: Leech Therapy; Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)
No infected	Other: Leech Therapy; Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)
bacterial infection	Other: Leech Therapy; Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of patients requiring a second surgery	9 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Leeches; Healthcare-associated infection; Hirudo Medicinalis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Iatrogenic Disease; Cross Infection
• Other Study ID Numbers: PI2020_843_0136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No