Nitric Oxide Generating Gel Dressing in Patients With Superficial Partial Thickness Wounds

Study Overview
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Brief Summary
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This is a study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on superficial partial thickness (SPT) wounds. Nitric oxide has a range of effects on the body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 160 patient, randomised, controlled clinical study will assess the ability of a simple 2 part, NOx generating dressing to improve healing in SPT burn wounds and SPT skin graft donor site wounds compared to standard of care.

Detailed Description
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This is a clinical study of a new wound dressing for superficial partial thickness (SPT) wounds. The dressing consists of 2 stable layers that when placed together release Nitric Oxide. In preclinical studies NOx delivery has caused significant vasodilation, angiogenesis and demonstrated potent anti-microbial activity. This is a multi-centre, 160 patient, randomised, controlled study. There are 2 arms to the study. 80 patients will have treatment applied to a SPT burn wound and 80 patients will have treatment applied to a SPT graft donor site wound. The controls will be intra-individual. Each patient will have their wound divided into 2, half of the wound being treated with the NOx dressing, the other half treated with standard of care. The positioning of the dressings will be randomised. The NOx dressing will be changed at least every 2 days and the standard of care changed according to normal clinical practice and patients will be treated until the wound is healed. The study will evaluate: The size of the wound Eepithelialisation Trans-epidermal water loss Infection status. There will be 3 and 12 month follow up with assessment of scarring.

Official Title
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ProNOx 2 - A Clinical Study of Superficial Partial Thickness Wound Treatment With an Oxides of Nitrogen Generating Gel Dressing

Conditions
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Superficial Partial Thickness Burn, Skin Graft; Complications

Intervention / Treatment
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* Device: NOx dressing
* Device: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have a Superficial Partial Thickness wound (2a) either from a thermal injury or from a skin graft donor site under the care of St. Andrews service, within the recruitment timeline. Wound area to be treated in study must be less than 5% of total body surface area (TBSA). Patients aged over 12 months and up to and including 80 years old. Informed Consent Exclusion Criteria: Any inclusion criteria not met Unwilling to consent to investigation/ unable to provide consent Wounds deeper than superficial partial thickness (2b, 3 and 4) Chemical /Electrical burns Already having received silver sulfadiazine Disease that could affect wound healing Previous participation in the study Females who are pregnant or breast-feeding. Relative, spouse or employee of the investigational site Known multiple allergic disorders Skin disorders Facial burns Patients who have taken part in any investigational studies within the last 30 days prior to participation.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SPT Burn Wound<br>Each wound will be divided into 2 with half the wound being treated with the NOx dressing and the other half with standard of care | Device: NOx dressing<br>* The NOx dressing should be changed at least every 2 days.<br>Device: Standard of Care<br>* Dressing changed as per normal clinical practice<br>|
| Other: SPT graft donor site<br>Each wound will be divided into 2 with half the wound being treated with the NOx dressing and the other half with standard of care | Device: NOx dressing<br>* The NOx dressing should be changed at least every 2 days.<br>Device: Standard of Care<br>* Dressing changed as per normal clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of days until healing (defined as 95% epithelisation) in SPT wounds treated with conventional Mepitel® dressing vs. investigational nitric oxide generating gel dressing |  | From randomisation and first application of the dressing, patients are assessed every 2 days until 95% epithelialisation occurs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of healing by blinded evaluation of photographs |  | Every 2 days from baseline until 95% epithelialisation occurs | 
| Cosmetic Outcomes measured using both the Vancouver Scar Scale and the Patient Observer Scar Assessment Scale |  | 3 and 12 months post healing | 
| Colonisation of wounds | Wound swabs will be taken at every patient visit, every 2 days, until 95% epithelialisation occurs. | Baseline and every 2 days therafter until 95% epithelialisation occurs | 
| Tolerance and safety of the dressing | Assessment of reported adverse events | Baseline and every 2 days thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitric Oxide Dressing, Nitric oxide, Superficial partial thickness wound, Burns, Skin graft donor sites, Improved healing, Vasodilation, Angiogenesis, Anti-microbial