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The study was paused initially pending a review of the study design. The decision was then taken not to resume the study.
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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.
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:
There will be 3 and 12 month follow up with assessment of scarring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPT Burn Wound | Other | 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 |
|
| SPT graft donor site | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOx dressing | Device | The NOx dressing should be changed at least every 2 days. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Stewart, PhD | Queen Mary University London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Andrew's Centre for Plastic Surgery and Burns, Broomfield Hospital | Chelmsford | Essex | CM1 7ET | United Kingdom | ||
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| ID | Term |
|---|---|
| D002056 | Burns |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Standard of Care | Device | Dressing changed as per normal clinical practice |
|
| 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 |
| Canniesburn Regional Plastic Surgery and Burns Unit, Glasgow Royal Infirmary, |
| Glasgow |
| G4 0SF |
| United Kingdom |