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NCT04676581: AMLEE
Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years
trial testing Leech Therapy in Leeches in 37 participants. Completed in 15 December 2020.
15 December 2020
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire, Amiens |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 37 |
| Start date | 15 December 2020 |
| Primary completion | 15 December 2020 |
| Estimated completion | 15 December 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- Leech Therapy — full drug profile →
Conditions studied
- Leeches — all drugs for Leeches →
- Healthcare Associated Infection — all drugs for Healthcare Associated Infection →
Sponsor
Centre Hospitalier Universitaire, Amiens
Who can join
6 and older, any sex, with Leeches or Healthcare Associated Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04676581
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04676581 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire, Amiens
- Last refreshed: 21 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04676581.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing