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

Healthcare Associated Infection Clinical Trial

— AMLEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676581
• Other study ID #: PI2020_843_0136
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cross Infection
• Healthcare Associated Infection
• Leeches

Intervention

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)

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients requiring a second surgery		9 years