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

NCT ID: NCT04676581

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2020-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leeches Healthcare Associated Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Leeches Healthcare-associated infection Hirudo Medicinalis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aeromonas infection

Leech Therapy

Intervention Type OTHER

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

No infected

Leech Therapy

Intervention Type OTHER

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

bacterial infection

Leech Therapy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Leech Therapy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Amiens

Amiens, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI2020_843_0136

Identifier Type: -

Identifier Source: org_study_id