Cutaneous Ulcer, Yaws, Yaws; Cutaneous
Conditions
Brief summary
In a search for accessible treatment options, plant medicines used by different communities in Papua New Guinea have been tested to identify the sap of the tree, Ficus septica, as a promising antibacterial agent in vitro. This is an open label clinical trial using an interventional approach, to compare the effect of the antiseptic plant sap and 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.
Detailed description
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.
Interventions
BIOLOGICALTopical antiseptic treatment
Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.
Sponsors
The University of Papua New Guinea
The Royal Botanic Gardens, Kew
Oriol Mitja
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessor of healing outcomes through pictures will not know the arm of origen of the pictures .
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Clinical Healing in each arm | 21 days | surface reduction by more than 50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Papua New Guinea
Outcome results
None listed