Ulcer Foot

Diabetic Foot Ulcer

HBOT

Standard wound care

Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:

Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer: A Prospective Double-Blind, Randomized Control Clinical Trail

The change of wound size at 4 weeks (granulation formation) as measured by the Silhouette three dimensional photography

King Hamad University Hospital, Bahrain

University of Stellenbosch

CRP analysis will be performed during the consultation in accordance with the manufacturer's instructions.
The CRP point of care test will be performed in case of a positive decision tree (irrespective of the intervention group) and also in case of a negative decision tree by clinicians of intervention group 1 and 2. Because no reliable cut-off points for CRP are known currently (as this is the aim of this study) for acute infections in children in primary care (nor for referral, nor for prescription of antibiotics), clinicians will not be given guidance on the interpretation of the CRP results.
We will not impose restrictions on the clinicians about treatment, other technical investigations nor referrals.
The device distributor will provide technical assistance. All clinicians will be trained in the use of the CRP device prior to the start of the study.

Combination of CRP POC test and the brief intervention & parent information leaflet intervention groups (factorial design)

Sepsis

Bacteraemia

Meningitis

Abscess

Pneumonia

Osteomyelitis

Cellulitis

Gastro-enteritis With Dehydration

Complicated Urinary Tract Infection

Viral Respiratory Infection Complicated With Hypoxia

Use of C-reactive protein (CRP) point of care test

Brief interventions are commonly used to give opportunistic advice, discussion, negotiation or encouragement. Mostly they take between 5 to 10 minutes. We developed a brief intervention: we'll ask the clinicians to ask 3 specific questions, namely "Are you concerned?", "What exactly concerns you?" and "Why does this concern you?". This intervention is easy to implement in daily practice and no additional training is required.
We developed a parent information leaflet that gives information about what they can do when their child is ill, which signs are important to follow up and when they really should get advice from a clinician. This could make it easier for them to cope with an ill child. The clinician could use this leaflet to give advice and make clear when they have to re-consult their physician to re-evaluate the child. Our hypothesis is that through creating this safety net, the improper demand for antibiotics could be reduced.

Brief intervention and parent leaflet

All physicians will be asked to perform a measurement of the oxygen saturation on all children and enter the results on the case report form. The selected device is a clip-on system suitable for use in children, which measures oxygen saturation in the capillary blood as well as the pulse rate.

Finger Pulse Oximeter

Universitaire Ziekenhuizen Gent

Universitaire Ziekenhuizen Leuven

Optimising Diagnosis and Antibiotic Prescribing for Acutely Ill Children in Primary Care

Validation of a Vital Signs and Symptoms Decision Tree and the Effect of a Point-of- Care CRP Test, Oxygen Saturation, a Brief Intervention and a Parent Leaflet on Diagnosing, Antibiotic Prescribing Rate and Parental Satisfaction in Acutely Ill Children in Primary Care."

To verify if the child had a serious infection after consulting the primary care physician, the research team will consult all hospital records within the referral region of the physicians to check whether the child was admitted to hospital with a serious infections, based on the appropriate reference standards.
In case of referral and/or hospitalisation, the primary care and hospital clinicians will be contacted to reconstruct the illness episode (reason for referral/hospitalisation, diagnosis, time to cure).

The recruiting physicians are asked to fill out whether and which kind of antibiotics they prescribed during the assessment of the sick child. The registration forms will be assessed at 1 year, when the study recruitment phase ends.

osteomyelitis/hypoxia

Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:

Optimising Diagnosis and Antibiotic Prescribing for Acutely Ill Children in Primary Care

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