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

NCT04676581 | Completed

• 1 other identifier: PI2020_843_0136
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leeches; Healthcare Associated Infection

Keywords

Leeches; Healthcare-associated infection; Hirudo Medicinalis

Outcome Measures

Primary Outcomes (1)

• number of patients requiring a second surgery

  9 years

Study Arms (3)

Aeromonas infection

Other: Leech Therapy

No infected

Other: Leech Therapy

bacterial infection

Other: Leech Therapy

Interventions

Leech Therapy OTHER

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

Aeromonas infection; No infected; bacterial infection

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• Hirudotherapy or less than 2 days of treatment

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Cross Infection

Interventions

Leeching

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: December 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)