Superficial partial thickness wound treatment with NOx

• Research type

  Research Study

• Full title

  A clinical feasibility study of superficial partial thickness wound treatment with an oxides of nitrogen (NOx) - generating gel dressing

• IRAS ID

  126571

• Contact name

  Joanne Stewart

• Contact email

  j.e.stewart@qmul.ac.uk

• Sponsor organisation

  Edixomed Limited

• Research summary

  We propose to conduct a clinical pilot study of our new, patented nitric oxide (NOX) generating technology, in secondary partial thickness burn wounds and donor skin graft sites. We have developed this technology into an economical, easy-to-use dressing system to stimulate healing in a variety of wounds. The technology has been shown in early clinical studies to improve blood flow, control infection and promote wound healing.
  Superficial partial thickness (SPT) wounds consist of loss of the outermost layer of the skin (epidermis) with a small amount of dermis. These wounds generally heal within 10-17 days due to the epidermis. These wounds would generally self-heal with only a non-adherent dressing and secondary layer to protect from potential of infection.
  As for any burn injury, the first 48 hours are important. A small percentage of these burns, instead of moving towards healing, will progress to deeper injuries, with a worse prognostic outcome; and as yet it is difficult to clinically determine in which cases this will happen. There is recent evidence to suggest that nitric oxide donors, perhaps by improving vascular perfusion in the surrounding tissues, may actually limit damage and prevent this progression (Tobalem et al; 2012). Our dressings provide the first genuine clinical application of this type of technology. The NOx-generating dressing we have developed is a two-layer system, allowing the active ingredients to be kept separate until the dressing is applied to the wound. The current study will assess the compliance, safety and tolerability of the dressing system. Assessments of the effects on blood flow and wound status will be performed.

  This study will be conducted at St Andrew’s Centre for Plastic Surgery and Burns. Dependent on results of the current study, future Phase II/III studies will be conducted in other centres across the UK.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  13/LO/0579

• Date of REC Opinion

  28 Jun 2013

• REC opinion

  Further Information Favourable Opinion