Nitric Oxide Generating Gel Dressing in Patients With Superficial Partial Thickness Wounds (NCT01983085) | Clinical Trial Compass
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 range
1 Year
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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