Non-medicinal Treatment of Cutaneous Leishmaniasis

Transcription

1 Waisenmedizin (WM e.v.) PACEM Promoting Access to Care with Essential Medicine Your Partner to Defend Patients Interests Non-medicinal Treatment of Cutaneous Leishmaniasis PhD. Student: Ahmad Alali Prof. Dr. Kurt-W. Stahl & Prof. Dr. Kurt Bauer

2 Waisenmedizin (WM e.v.) PACEM NGO: Non Governmental Organization NPI: Non-Profit Initiative Founded on May 19 th Sister NGO in Switzerland in 2013 Waisenmedizin-PACEM (WM) Physicians and Pharmacist and Chemists. Interest: the neglected diseases. Area of Work: Algeria, Iran, Afghanistan. Now in Syria.

3 Products for non-medicinal CL Treatment Product Company Notes LeiClean LeiProtect Prontosan Minicutter Dermojet WHO: Clean Hands Save Lives Waisenmedizin. e.v B BRAUN (Switzerland) KLS MARTIN (Germany) AKRA DERMOJET (France) Alcohol Based Handrub WHO Formulation I Non-medicinal Cellulose Gel Protect the Leishmania lesions Wound irrigation and cleansing Remove LeiProtect every week Treatment the lesions with HF-bipolar electrosurgery (ES) Needle free painless intradermal injection

4 WHO-recommended Handrub Formulations for Leishmania wound care LeiClean

5 LeiProtect Invisible Film For Leishmania Lesion Protection Je le pansai, Dieu le guérit Ambroise Paré Applying LeiProtect on the lesions after cleaning the hands with LeiClean. Dries after min transparent film stays intact for 24 hrs. Applying a new layer on top of the old one every 24 hrs. Removing the 6 layers after 6 days with Prontosan. Taking photos to observe the healing of the lesions. Documentations. Semi-Solid Cellulose Dressing

6 Prontosan Betaine 0.1 g%: gentle effective surfactant to penetrate, clean and remove wound debris and biofilm. Polyhexanide (PHMB) 0.1g%: a powerful antimicrobial agent that can reduce germ load (5.400 µm)

7 Advantages of using Prontosan Reduction of germ load Safe for long term use Advantages Prontosan Saline Water Antiseptic No inhibition of granulation tissue Clinical evidence in reduction of pain and odour Can be used up to 8 weeks after opening - cost effective N/A Clinical evidence in reduction of infection rates Clinical evidence in improved healing times

8 PHMB against L.major Firdessa R1, Good L2, Amstalden MC3, Chindera K2, Kamaruzzaman NF2, Schultheis M1, Röger B1, Hecht N3 Oelschlaeger TA1, Meinel L3, Lühmann T3, Moll H1. Pathogen- and Host-Directed Antileishmanial Effects Mediated by Polyhexanide (PHMB). PLoS Negl Trop Dis Oct 2;9(10):e doi: /journal.pntd ecollection 2015 IC50 against promastigotes: 0.41 µm 39-fold more potent than Pentamidine. 69-fold more potent than Miltefosine fold more potent than Paromomycin. Antileishmanial effect equal to Amphotericin B IC50 against intracellular amastigotes: 4 µm Suggested mechanism of action is: condensation and disruption of parasite chromosome

9 LeiClean & LeiProtect case from Mazar-e-Sharif, 03/14 14 weeks 2 weeks 0 week

10 Scientific track record of WM e. V. Median healing time for classical treatment = topical Sb (V) : 9 weeks Mazar trial, mixed population: L. major+tropica Median healing time for CL wound debridement and classical gauze dressing without ABHR: 4.9 weeks Median healing time of complex L. Major caused CL 4 Weeks Therapy: ABHR + Leiprotect without bipolar HF ES debridement Semi-solid cellulose dressing (LeiProtect ); ABHR (WHO-Formula 1) "Cutaneous Leishmaniasis Healing Can be on the Tip of the Patient's Clean Disinfected Finger Study Report for BfArM acc. to 11 MPG, unpublished 10 Prof. Dr. Dr. K.-W. Stahl

11 Characteristics of CL wound care LeiClean & LeiProtect (see abstract ECMID 04/2017) Relies on the host s immune defence, no antiparasitic treatment Involves the patients into their treatment Focusses on CL as wound disease Low Direct Costs Complex CL lesions (L. major) can be healed without systemic Sb (V) Protection from superinfections & sand fly bites (L.tropica)

12 Stahl et al. PloS Infectious Diseases Bipolar high-frequency (HF) electro-surgery (ES) of cutaneous leishmaniasis (CL) ulcers and subsequent moist wound treatment (MWT) closed 90% of all Leishmania (L.) tropica lesions within 60 and 100 days depending on the lesion tissue parasite load of <10 5 and >10 5 parasites per g of tissue. Minicutter for bi-polar HF electrosurgery

13 Instrument used for bi-polar HF Electrosurgical Debridement Bipolar HF ES can be performed using a 12 V car battery allowing to cauterize the CL wounds ( en cautérisant les plaies ) acc. to what was practised in war surgery before Ambroise Paré promoted wound dressing in the 16 th century The retail price of the thermotherapy device used by Reithinger et al. is >7fold (US $23,450)

14 OWCL wound debridement (Kabul trial, L. tropica only) CL lesion of boy aged 13, post debridement dressing with % NaClO 2 in polyacrylate jelly. A: Pre-treatment lesion with initiating ulceration located on the forerarm, B 1 = 11,200 L/g B: 2d after ETC, wound coated with fibrin C Formation of granulation tissue encircled by initiating epithelisation after 14d. D: Progressing epithelisation (30.d), E: complete wound closure after 50d, B 2 (after 54 days) = 0 F: Follow up after 9 mo. revealed a flat and slightly hyper pigmented scar

15 OWCL wound debridement (Kabul trial, L. tropica only) CL lesion of boy aged 12, post debridement dressing with physiol. saline in polyacrylate jelly. A: Ulcerated lesion before treatment located on the forearm. B: 4 d after EC, C: Formation of granulation tissue and beginning epithelialization after 15 d, D: Progressing epithelialization (d 19), E: Complete wound closure after 27 d, F: Follow-up after 20 months revealed a flat scar with hyperpigmentation.

16 OWCL wound debridement (Kabul trial, L. tropica only) CL lesion of male aged 63, post debridement dressing with physiol. saline in polyacrylate jelly. G: Lesion on the upper arm with early ulceration prior to treatment. H: 4 d after EC, I: Formation of granulation tissue covered with fibrin and beginning epithelialization after 8 d, J: Progressing epithelialization (14 d), K: Complete wound closure after 16 d, L: Follow-up after 14 months revealed a flat scar.

17 Growing practice of CL wound debridement vs. chemotherapy in Kabul H. Darmangar, MD thesis, Med. Faculty of Freiburg in preparation

18 Healing of CL wounds caused by L. tropica in Kabul - A retrospective analysis H. Darmangar, MD thesis, Med. Faculty of Freiburg in preparation Kaplan-Meier Healing Analysis after bipolar ES debridement First 200 patients of a total of 2,300 cases Kaplan-Meier Healing Analysis after Sb (V) First 40 patients of a total of 160 cases

19 AKRA DERMOJET Needleless Syringe The DERMOJET injects 50µl of all types of liquid as intradermic projection (e.g. local anesthetics, drugs) : Without the use of a needle, Painlessly and without contact with the patient's skin Used by more than Doctors around the world

20 Bipolar HF Electrosurgery* with Dermojet Anaesthesia** * Physical parasite destruction No resistance problems *Wound closures faster than with Sb (V) Advanta ges vs. topical Sb (V) ** Direct Costs **Less pain