Improvement of patient care through hirudotherapy and the management of leeches from their reception to their disposal in France

Abstract

Objective

Medicinal leech therapy — known as hirudotherapy (HT) — is an empirical medical technique that has become popular again in reconstructive surgery. However, at each step of leech management there are risks for blood contamination of the caregivers and severe infections for patients. This reduces the success of the treatment. The aim of this study was to improve the management of leeches from ordering to disposal to improve patient care.

Methods

First, a review of the literature was performed. Second, we conducted a retrospective study of patients’ antibiotic prophylaxis from January 2018 to December 2019. The data we collected were patient characteristics, the specific care unit at the hospital, indication, contra-indication, posology, duration of HT, number of leeches delivered, antibiotic prophylaxis prescribed and microbial organism, if identified. Third, an interdisciplinary meeting was organised to review the entire leech circuit: ordering, maintenance, prescription, dispensing, application and disposal.

Results

At the end of the literature review, six articles based on practices implemented in France were selected for inclusion. These articles discussed antibiotic prophylaxis, iron supplementation, and leech storage, application and disposal. On the retrospective study performed, antibiotic prophylaxis for HT was performed for 60% (30/50) of patients, 77% (23/30) of the prescriptions followed the recommendations for antibiotic prophylaxis, and 20 patients did not receive antibiotic prophylaxis. The interdisciplinary meeting made it possible to define a collegially validated protocol, containing a computerised antibiotic prophylaxis prescription, including per os ciprofloxacin antibiotic prophylaxis, intravenous iron supplementation and biological monitoring. A leech application protocol was created, and the method of leech disposal was revised.

Conclusion

Despite the absence of clear guidelines and heterogeneous practices, this study reveals the importance of a standard procedure including leech management practices before use, antibiotic prophylaxis and application and disposal guides. The interdisciplinary protocol allows improved patient care management and makes leech management safer for caregivers.

Introduction

Two thousand years ago, in ancient Egypt leeches began to be used for medicinal purposes. In recent years leeching, known as hirudotherapy (HT) has again become popular.¹ HT is the use of medicinal leeches, Hirudo medicinalis, in cases of patient venous insufficiency of pedicled or free flaps when revision surgery is not recommended. Venous congestion is a post-operative complication of plastic/reconstructive surgery causing tissue necrosis. During the last two decades, using HT has increased because of the effectiveness of leeches.² The leeches’ salivary secretions contain substances such as hirudin, a natural anticoagulant and hyaluronidase, which increases tissue permeability. These substances allow the improvement of tissue perfusion and improve the flap rescue rate by 70%.³ However, leeches carry symbiotic bacteria in their digestive tract, which can be responsible for human infections. The most common microorganisms are Aeromonas spp., which are gram-negative, facultative anaerobic bacteria capable of causing major tissue necrosis, soft tissue and muscle infections.^{4 5} An infection reduces the chance of saving the flap to 30%, and infection is usually severe.⁶ A unique case of Aeromonas meningitis associated with HT has also been described in the literature.⁷ Another side effect of HT is blood loss requiring blood transfusions.⁸ Despite these risks, only a meta-analysis on the recommendations of this practice in France has been carried out. There are no clear guidelines on good leech management practices before use, on the necessary antibiotic prophylaxis, or on the application of leeches or their disposal.⁹ In France, only one firm (Ricarimpex) supplies medicinal leeches. This firm provides some recommendations on leech management but they are not exhaustive. In general, the main surgical units using leeches are maxillofacial, plastic and reconstructive surgery and orthopaedic surgery departments. Concerning leech management, the circuit includes ordering, reception, maintenance, prescription, dispensing, application and disposal. At each step of this circuit, there are specific risks, i.e., the risk of leech losses at the reception-storage and dispensing steps and blood exposure risks at application and disposal steps. More specifically, from the literature analysis, at the prescription step, practices of antibiotic prophylaxis vary, and recent studies on HT suggest this treatment remains a current issue, given it can lead to a risk of infection for the patient.¹⁰

This study aimed to implement an institutional leech management protocol from ordering to disposal to improve the management of patients receiving HT in a university hospital.

Method

The study was conducted in a 1495-bed French university hospital where HT was mainly practiced in the orthopaedic surgery department (54 beds) and in the maxillofacial, plastic and reconstructive surgery department (38 beds).

First, a literature review was conducted via an electronic search on PubMed and ScienceDirect using the following search terms: (“leech” or “leeches”) and (“antibiotic prophylaxis” or “antibiotic therapy” or “leech therapy”or “hirudotherapy” or “leech management”) (figure 1). The literature was searched from 1 Jan 1990 to 1 June 2020. The date of the last search was 2 June 2020 and focused on practices in France, in order to compare them with those of the hospital in this study.

Figure 1.

Flow chart of the study selection process. Search terms included (“leech” or “leeches”) and (“antibiotic prophylaxis” or “antibiotic therapy” or “leech therapy” or “hirudotherapy” or “leech management”).

Second, a retrospective study of patients’ antibiotic prophylaxis in the hospital was performed. This study included all patients treated with HT from January 2018 to December 2019. Our university hospital has collective information and a commitment to MR04. MR-004 method provides a framework for the processing of personal data for the purpose of study, evaluation or research not involving the human person. Patients have been informed in the various departments involved and can opt-out from having their health data used. The study data were collected from medical records using M-Crossway (Maincare, Canejan, France) and included patient characteristics (sex, age), the care unit of the hospital, indication, contra-indication, posology, the duration of HT, the number of leeches delivered, the antibiotic prophylaxis prescribed (indication, posology, duration) and the microbial organism, if identified.

Third, an interdisciplinary group of medicinal leech prescribers (infectious disease specialists (IDSs), orthopaedic and maxillofacial surgeons), a microbiologist, a hygienist and hospital pharmacists were assembled to review patient cases.

The entire leech management circuit was reviewed:

• Ordering, reception and maintenance

• Institutional computerised prescription protocol containing antibiotic prophylaxis

• Dispensing

• Application

• Disposal

A standard protocol for the management of patients treated with HT was decided at the end of this meeting.

Results

At the end of the literature review process, 39 studies were selected (figure 1). The selected studies were conducted in 12 countries: the United States of America (n=19), France (n=6), the Netherlands (n=3), Germany (n=2), Israel (n=2), Belgium (n=1), Poland (n=1), the United Kingdom (n=1), Canada (n=1), India (n=1), Turkey (n=1) and Japan (n=1).

Concerning the six studies based on practices in France (table 1), the first study (Maetz, Abbou, Andreoletti et al) presented case reports and a literature review.¹¹

Table 1.

Summary of the six studies based on practices in France

Title	Author	Location	Year	Journal	Type of article	Theme
Infections following the application of leeches: Two case reports and review of the literature11	Maetz B, Abbou R, Andreoletti JB, et al	University Hospital of Strasbourg, Strasbourg	2012	Journal of Medical Case Reports	Case report	Antibiotic prophylaxis Leech-related infections
Multidisciplinary reflection on the use of leeches in healthcare facilities12	Perrier Q, Parmentier R, Bros A, et al	University Hospital of Grenoble-Alpes, Grenoble	2018	Pharmacien Hospitalier et Clinicien	Original article	Leech management Antibiotic prophylaxis
Leech management before application on patient: a nationwide survey of practices in French university hospitals2	Grau D, Masson R, Villiet M, et al	University Hospital of Montpellier, Montpellier	2018	Antimicrobial resistance and infection control	Original article	Leech management
Leech therapy in flap salvage: systematic review and practical recommendations13	Herlin C, Bertheuil N, Bekara F, et al	University Hospital of Lapeyronie, Montpellier	2017	Annales de Chirurgie Plastique Esthétique	Review	Antibiotic prophylaxis Leech-related infections Practical recommendations
Transmission of Aeromonas hydrophila by leeches10	Sartor C, Bornet C, Guinard D, et al	Hospital of Conception, Marseille	2013	The Lancet	Case report	Antibiotic prophylaxis Leech-related infections
Medicinal leech therapy and Aeromonas spp. infection14	Verriere B, Sabatier B, Carbonnelle E, et al	Georges Pompidou European Hospital, Paris	2016	European journal of clinical microbiology & infectious diseases	Original article	Antibiotic prophylaxis Leech-related infections

The second study (Perrier, Parmentier, Bros et al) was a multidisciplinary reflection on the use of leeches in healthcare facilities.¹² The third study (Grau, Masson, Villiet et al) presented a nationwide survey of practices in French university hospitals.² The fourth study (Herlin, Bertheuil, Bekara et al) was a systematic review and discussion of practical recommendations.¹³ The fifth study (Sartor, Bornet, Guinard et al) was about the susceptibility of strains of Aeromonas isolated from water samples and crushed leeches, and the sixth study (Verriere, Sabatier, Carbonnelle et al) was a case report on the transmission of Aeromonas hydrophila during HT.^{10 14} Case reports, multidisciplinary reflections and the article about Aeromonas susceptibility were used to create a proposal for antibiotic prophylaxis. The article including the systematic review and practical recommendations allowed the exploration of application methods and the use of iron supplementation. The nationwide survey of practices was also included for storage conditions (type of water, frequency of water change and temperature) and for waste disposal. The literature review led to the creation of two documents: a leech management circuit in the hospital which was approved by the multidisciplinary group (figure 2) and a leech application guide (figure 3).

Figure 2.

Different steps of the leech management circuit validated by the multidisciplinary group.

Figure 3.

Leech application guide. A⁹, B¹³.

During the retrospective study conducted in the hospital from January 2018 to December 2019, 50 patients were treated with HT (sex ratio M/F=1.78). The average duration of leech use was 4 days.^{1 11} Over 2 years, 3185 leeches were delivered with an average of 64 leeches per hospitalisation. Fifty-two percent of leech prescriptions (26/50) came from the orthopaedic surgery department, compared with 48% (24/50) from the maxillofacial surgery department. The highest number of leeches delivered for one patient was 212 during three different hospitalisations for a lip flap in the otorhinolaryngology department.

Antibiotic prophylaxis for HT was performed for 60% of patients (30/50) with an average duration of 5 days. Seventy-seven percent of the prescriptions followed the recommendations of ciprofloxacin and sulfamethoxazole/trimethoprim (with a variation of the dosage between patients) for antibiotic prophylaxis, and 20 patients did not receive antibiotic prophylaxis. Two leech-related infections were found in two patients who did not receive antibiotic prophylaxis. Aeromonas veronii was isolated from these two cases. No leech infection was found in patients that received antibiotic prophylaxis (table 2).

Table 2.

General characteristics of patients included in the study and antibiotic prophylaxis

Antibiotic	None n=20	Levofloxacin n=1	Ciprofloxacin n=5	Ciprofloxacin +metronidazole n=1	Ciprofloxacin +SMX/TMP n=23
Posology	N/A	750 mg DIE (n=1)	750 mg BID (n=1) 500 mg BID (n=4)	750 mg BID +500 mg TID (n=1)	500 mg BID+800/160 mg BID (n=18) 500 mg BID+800/160 mg DIE (n=3) 500 mg DIE +800/160 mg DIE (n=1) 500 mg BID+400/80 mg DIE (n=1)
Average duration (days)	N/A	11	4.8	5	3.3
Patient characteristics (n=50)
Male	17	0	2	1	12
Female	3	1	3	0	11
Age, median (years)	50	79	55	33	61
Leeches
Quantity of leeches dispensed	60	169	78	75	59
Average duration (days)	4.2	11	4.8	5	3.3

BID, twice a day; DIE, once a day; N/A, not applicable; SMX/TMP, sulfamethoxazole/trimethoprim; TID, three times a day.

During the multidisciplinary meeting involving IDSs, orthopaedic and maxillofacial surgeons, hygienists and hospital pharmacists, a survey of practice in the hospital was presented. A consensus protocol was developed from the literature review. An update of best practice procedures for using leeches was then drafted by the pharmacists (figure 2).

The first step of the procedure was the order. As hirudotherapy is an emergency treatment, it was decided to set a minimum stock level of 200 leeches. The stock level is checked weekly by pharmacy students or by the pharmacist during maintenance and at each dispensing. If the stock is under the defined threshold, they notify the pharmacy dispenser to order more stock. The second step was reception and maintenance: leeches were stored in jars containing still bottle water. A maximum of 30 leeches are stored per jar, away from light and at temperatures between 2°C and 8°C. Stocks can be traced using the label on the jar which identifies the contents, batch number, expiration date, number of leeches and date of water change. Leech maintenance was performed weekly and jars were decontaminated with soap and alcohol. The jars were rinsed with non-carbonated bottle water to avoid toxicity to the leeches.

The prescription was simplified using an institutional computerised protocol including per os ciprofloxacin antibiotic prophylaxis (ciprofloxacin 500 mg twice a day, for 5 days with a re-evaluation at Day 5), intravenous iron supplementation and biological monitoring (figure 2). Following the review of the literature, pharmacists and surgeons discussed the use of iron supplementation. The choice made in the final protocol was an injection of 300 mg iron every 3 days during HT.

Leeches were dispensed, without any type of external decontamination, in jars containing a maximum of ten leeches. The application and disposal protocol was provided with the leeches, and an empty jar was used for the disposal of leeches in the care unit.

A leech application protocol was created to standardise practices. This explained the two methods of application for the nurses involved in patient care: the syringe method and the compress method (figure 3).

Finally, the method of leech disposal was revised. Before this project, leeches were normally returned to the pharmacy after use. However, during the interdisciplinary meeting a decision was taken that nurses in the care unit would eliminate the leeches directly after use with a small container of bleach. The disposal of leeches directly after use in the care unit makes this disposal step more secure (figure 3. This step reduces the risk of blood exposure due to individual transport and the receipt of used leeches. Our work and procedure was presented to and validated by the local hospital Anti-Infective Drugs Committee.

Discussion

This study concerns the entire leech circuit from order to disposal to optimise treatment by HT. After showing the importance of antibiotic prophylaxis, organising a multidisciplinary meeting and drafting a computerised protocol, this work also takes into consideration the risks associated with the application and disposal of leeches. Indeed, a poor application of leeches can lead to significant blood loss requiring a transfusion. This can be the case when a vein or artery is bitten.¹⁵ This risk is curtailed with our leech application guide. The risk of exposure to blood during disposal is also reduced by the new leech disposal procedure.

To carry out this project, we selected only six studies focusing on French university hospitals because this is where reconstructive surgery is concentrated. The studies in France are the most similar to our practices and are the most reproducible.

In our hospital, many leeches are delivered to care units, and the study carried out shows a wide variety of practices due to the absence of a standard protocol. The choices of antibiotic, dosage and duration were variable, and antibiotic prophylaxis has been shown to be unsuccessful in our hospital. Indeed, some patients did not benefit from antibiotic prophylaxis, which showed a risk of leech-related infection. The multidisciplinary meeting made it possible to standardise practices and produce a protocol for use of leeches.

Leeches are stored in the pharmacy which allows better control of leech management. Indeed, it was shown that when leeches were stored in surgical units in a jar that was not regularly decontaminated, leech-related infections were twice as frequent (4.1% vs 2.4%). The storage conditions chosen were those recommended by the supplier and are the most commonly used in France.² Storage in the pharmacy also results in improved traceability, enabling an investigation in cases of nosocomial infection occur.

In 39% of French hospitals, external decontamination is carried out before the application of leeches.² However, the supplier does not provide recommendations on whether or not leeches should be disinfected. It is not part of our protocol because, to our knowledge, no study has shown its effectiveness.

The literature review has shown the importance of antibiotic prophylaxis. Indeed, the rate of infection after HT is 14%.¹ The most reported drugs used for prophylaxis in the literature were cephalosporins (3GC), fluoroquinolones and sulfamethoxazole/trimethoprim. The recommended dosages were sulfamethoxazole/trimethoprim 800 mg/160 mg twice a day +ciprofloxacin 500 mg twice a day. However, as found in our study, the antibiogram testing of 193 species of Aeromonas showed 100% sensitivity to ciprofloxacin.¹⁶ Therefore, in the multidisciplinary meeting, per os ciprofloxacin 500 mg twice a day was chosen. Although resistance can occur spontaneously by point mutation in the genes coding for gyrase and topoisomerase, according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) the distribution of MICs in Aeromonas hydrophila is relatively low and generally <0.125 mg/L. This decision helps clinicians to limit antibiotic overuse. Antibiotic prophylaxis will be re-evaluated if cases of ciprofloxacin resistant Aeromonas appear in the hospital.

A common side effect of leeching is constant blood loss, although this is not quantifiable in a post-surgical setting. Indeed, in a post-surgical setting, some patients were rehydrated with glucose or sodium chloride, which renders the haemoglobin values not comparable. Moreover, iron reserves assessed by ferritin, is not interpretable in this inflammatory context. To monitor this, it was decided to perform a complete blood count (CBC) and platelet count once a day for 5 days and to provide iron supplementation to the patient. To avoid drug interactions between oral iron and ciprofloxacin chelation, iron supplementation should be prescribed intravenously.

When leeches are dispensed, the application protocol is also provided to ensure proper use of the leeches. This protocol was determined according to the recommendations of the French supplier, allows non-traumatic handling of leeches and ensures good hygienic conditions when they are handled.

We also provide an empty jar and the elimination procedure document to secure this step, which was previously done by the pharmacy, thereby preventing the blood exposure risk during transport. Because of the specificity of leech use, it is important to support care units.

Conclusion

Hirudotherapy, particularly in terms of leech management, remains a hot topic in terms of good patient management and caregiver safety. This study reveals the importance of a standard procedure describing each stage of leech management to ensure optimal and safe management during HT, as this therapy is associated with a risk of severe infections. Although the literature is currently heterogeneous and no official guidance exists, it is important to formulate an institutional protocol to standardise practices and reduce the risk of infection. Means such as antibiotic prophylaxis, an application guide and a protocol for the management and elimination of leeches can reduce these risks. This is an interdisciplinary approach that has made it possible to validate good leech use practices in the institution at each stage. Going forward, the correct use of this protocol should be promoted and assessed. A follow-up study could be conducted to show its effect on improving clinical outcomes.

Key messages.

What is already known on this topic

• Hirudotherapy can cause severe infections.

• Despite the knowledge of the risk of infections, there are no generalised recommendations for antibiotic prophylaxis during hirudotherapy.

• There are no guidelines on good leech management practices from ordering to disposal.

What this study adds

• This study concerns the entire circuit from ordering to disposal of leeches to optimise their management, taking into consideration the risks associated with each step.

• This study, led in France, shows the importance of antibiotic prophylaxis and iron supplementation. It proposes an institutional interdisciplinary protocol validated by the Anti-Infective Drugs Committee and included in computerised prescriptions.

How this study might affect research, practice or policy

• This study contributes to the improvement of leech management practices by providing a complete circuit (from order to disposal). The circuit could serve as a guideline for first-time implemention of this type of treatment.

• This article is essential for standardising practices thanks to its protocol prescribing antibiotic prophylaxis and iron supplementation.

• This study could be useful for other countries to compare their practices to those of France.

Data availability statement

No data are available.

Ethics statements

Patient consent for publication

Not applicable.

Ethics approval

Not applicable.