LeechesAMLEENCT04676581
Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years
An observational study of Leeches and Healthcare Associated Infection, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Leeches, Healthcare Associated Infection
- What is being tested?
- Leech Therapy
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2020to 15 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)
Who may be able to join
- Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)
Who cannot join
- Hirudotherapy outside the inclusion period
- Hirudotherapy or less than 2 days of treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Leech Therapy
- Keywords
- Leeches, Healthcare-associated infection, Hirudo Medicinalis
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leech TherapyOther
Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)
| Study group | Role | What they receive |
|---|---|---|
| Aeromonas infection | Not described Receives: Other: Leech Therapy | |
| No infected | Not described Receives: Other: Leech Therapy | |
| bacterial infection | Not described Receives: Other: Leech Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients requiring a second surgery
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start15 Dec 2020
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeechesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676581
- Sponsor's protocol ID
- PI2020_843_0136
- Acronym
- AMLEE
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years
- ClinicalTrials.gov ID
- NCT04676581
- Acronym / sponsor ID
- AMLEE / PI2020_843_0136
- Conditions
- Leeches, Healthcare Associated Infection
- Keywords
- Leeches, Healthcare-associated infection, Hirudo Medicinalis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aeromonas infection | – | Other: Leech Therapy |
| No infected | – | Other: Leech Therapy |
| bacterial infection | – | Other: Leech Therapy |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)
Key inclusion criteria (1 listed)
- Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)
Key exclusion criteria (2 listed)
- Hirudotherapy outside the inclusion period
- Hirudotherapy or less than 2 days of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leech TherapyPatient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018) | Other | Aeromonas infection, No infected, bacterial infection |
Primary outcome
number of patients requiring a second surgery
Time frame: 9 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Leeches
Active, not recruiting
Effects of Hirudotherapy, Phytotherapy, and Forest Therapy in Adults With Reduced Work Capacity or Special Needs
Participation Level Below 55% and/or Special Needs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leeches and Healthcare Associated Infection, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients requiring a second surgery (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.