TerminatedPhase 2

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

Stopped: The study was paused initially pending a review of the study design. The decision was then taken not to resume the study.

United Kingdom13 participantsStarted 2013-09

Plain-language summary

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.

Who can participate

Age range1 Year

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: From randomisation and first application of the dressing, patients are assessed every 2 days until 95% epithelialisation occurs

Trial details

NCT IDNCT01983085

SponsorEdixomed Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-03

View on ClinicalTrials.gov More Superficial Partial Thickness Burn trials