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An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

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Oriol Mitja
Collaborateurs
Kew Royal Botanic Gardens, UK
University of Papua New Guinea

Mots clés

Abstrait

The cutaneous ulcer is a painful and debilitating bacterial infection that is common in rural areas of Papua New Guinea (PNG). Systematic treatment with topical antiseptics such as chlorhexidine cream in theory represents a viable treatment option, but in reality, effective treatment of cutaneous ulcers in Papua New Guinea is greatly hindered by the remote and highly inaccessible areas that affected communities often live in. In a search for more accessible treatment options, plant medicines used by different communities in Papua New Guinea have been tested to identified the sap of the tree, Ficus septica, as a promising antibacterial agent in vitro. The sap displays comparable activity to chlorhexidine in disc diffusion assays with gram-positive bacterial wound pathogens. It also appears to dampen the pro-inflammatory responses of neutrophils by down regulating interleukin-6 expression. The sap forms a flexible plastic-like wound covering which may help deter flies from feeding on the wounds, and unlike chlorhexidine cream, the Ficus tree is easy to find where affected communities live. For this reason, this study aims to perform an open label clinical trial using an interventional approach, to compare the effect of this antiseptic plant sap and of a standard topical antiseptic, on the rate of wound development prevention and bacterial growth. If shown to be effective, this readily available plant medicine can provide a zero-cost treatment option in remote areas of PNG.

Rendez-vous

Dernière vérification: 05/31/2020
Première soumission: 06/20/2020
Inscription estimée soumise: 06/25/2020
Première publication: 06/30/2020
Dernière mise à jour soumise: 06/25/2020
Dernière mise à jour publiée: 06/30/2020
Date de début réelle de l'étude: 10/31/2019
Date d'achèvement primaire estimée: 11/21/2019
Date estimée d'achèvement de l'étude: 11/24/2019

Condition ou maladie

Yaws; Cutaneous
Cutaneous Ulcer
Yaws

Intervention / traitement

Other: Topical antiseptic treatment

Phase

Phase 2/Phase 3

Groupes d'armes

BrasIntervention / traitement
No Intervention: Soap and Water
Experimental: Ficus Septica Sap
Active Comparator: Chlorhexidine (Topical)

Critère d'éligibilité

Âges éligibles aux études 5 Years À 5 Years
Sexes éligibles à l'étudeAll
Accepte les bénévoles en santéOui
Critères

Inclusion Criteria:

-children aged 5 to 15 with parental consent and with one or more skin breaks of any nature (i.e. Skin cuts, scratch, scrapes or abrasion and mosquito bites) that are less than 1cm in major diameter. Written informed consent by parent or guardian will be required before enrolment.

Exclusion Criteria::

- All participants who have received medical treatment for skin ulcers up to 2 months prior to recruitment (azithromycin, amoxicillin, benzathine penicillin, etc.).

- Patients who require antibiotic treatment for another condition not-related to the study.

- Known history of hypersensitivity, allergic or adverse reaction to the study product.

- Patients presenting cutaneous ulcer more than 1cm

Résultat

Mesures des résultats primaires

1. Number of participants with Clinical Healing in each arm [21 days]

surface reduction by more than 50%

2. Number of participants with Clinical Healing in each arm [21 days]

Ulcer healing determined by a professional dermatologist, described as as: appearance of granulation tissue, healed borders, dry ulcer, no exudation.

Mesures des résultats secondaires

1. Changes in wound microbiology [21 days]

Up to five key pathogens identified by next generation sequencing of wound fluids will be quantified at Day 0 and at Day 21 for samples from each arm of the study

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