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Clinical Research

We undertake:-
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Healthy Volunteer Studies

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Clinical projects to evaluate and/or compare wound healing therapies ranging from Case Studies to multi-centre RCTs.

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Clinical projects to generate chronic wound-derived materials (e.g. wound fluids for laboratory investigations by sponsor companies).

Our services include:-

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Sourcing & evaluation of investigators/centres

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Preparation of study documentation
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  Protocol
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  Case Record Forms
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  Patient Information Sheet
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  Patient Consent Form

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Ethics submission & liaison (UK National Research Ethics Service)

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Negotiation with UK-NHS Research & Development (site specific)

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Study Monitoring & logistics

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Preparation of study reports for internal use or peer review publication

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Image (& acetate tracing) analysis of clinical trial wound photographs
clinical wound healing research
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Example
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Multiple (10) case study evaluation of a new foam dressing under short-stretch compression
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Purpose – to support out-licensing of product
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Product status – CE marked device
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Wound type – venous ulcer
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Wound status
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 low to moderate exudation
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 non-infected (clinical signs)
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 > 3 months duration
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Assessments (over 6 weeks)
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Closure (image analysis)
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Pain (between & at dressing change) - VAS
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Tissue composition of wound (image analysis)
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Peri-wound tissue status
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Ease of use (relative to comparable product)
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Adverse effects  
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Findings
v
Dressing performed well.
v
Considered equivalent to similar products – by clinician
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No adverse effects
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Outcome
v
Product has been out-licensed by client
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Clinical Trial Microbiology
We can provide microbiological analysis of clinical trial samples (wound  biopsies or surface wound swabs) using conventional microbiological  techniques.