Superficial Partial Thickness BurnPhase 2ProNOx2NCT01983085
Nitric Oxide Generating Gel Dressing in Patients With Superficial Partial Thickness Wounds
A Phase 2 study testing NOx dressing in people with Superficial Partial Thickness Burn and Skin Graft; Complications, run by Edixomed Ltd at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Superficial Partial Thickness Burn, Skin Graft; Complications
- What is being tested?
- NOx dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2013to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St Andrew's Centre for Plastic Surgery and Burns, Broomfield Hospital
Chelmsford, Essex, CM1 7ET
Canniesburn Regional Plastic Surgery and Burns Unit, Glasgow Royal Infirmary,
Glasgow, G4 0SF
About this study
Official title: ProNOx 2 - A Clinical Study of Superficial Partial Thickness Wound Treatment With an Oxides of Nitrogen Generating Gel Dressing
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.
Read the detailed description
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.
- Being tested
- NOx dressing, Standard of Care
- Keywords
- Nitric Oxide Dressing, Nitric oxide, Superficial partial thickness wound, Burns, Skin graft donor sites, Improved healing, Vasodilation, Angiogenesis, Anti-microbial
- Medical subject headings
- Burns, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOx dressingDevice
The NOx dressing should be changed at least every 2 days.
Standard of CareDevice
Dressing changed as per normal clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: NOx dressing; Device: 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 Receives: Device: NOx dressing; Device: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From randomisation and first application of the dressing, patients are assessed every 2 days until 95% epithelialisation occurs
Secondary outcomes (4)
Assessment of healing by blinded evaluation of photographs
Measured: 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
Measured: 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.
Measured: Baseline and every 2 days therafter until 95% epithelialisation occurs
Tolerance and safety of the dressing
Assessment of reported adverse events
Measured: Baseline and every 2 days thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMay 2014
Why it stopped: The study was paused initially pending a review of the study design. The decision was then taken not to resume the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Partial Thickness BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edixomed Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Stewart, PhD, Principal investigator, Queen Mary University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983085
- Sponsor's protocol ID
- EDX 120
- Acronym
- ProNOx2
- Status last verified
- Apr 2021
- First submitted
- 30 Oct 2013
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProNOx 2 - A Clinical Study of Superficial Partial Thickness Wound Treatment With an Oxides of Nitrogen Generating Gel Dressing
- ClinicalTrials.gov ID
- NCT01983085
- Acronym / sponsor ID
- ProNOx2 / EDX 120
- Keywords
- Nitric Oxide Dressing, Nitric oxide, Superficial partial thickness wound, Burns, Skin graft donor sites, Improved healing, Vasodilation, Angiogenesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was paused initially pending a review of the study design. The decision was then taken not to resume the study.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Edixomed LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPT Burn Wound | Other | Device: NOx dressing, Device: Standard of CareEach 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 | Device: NOx dressing, Device: Standard of CareEach wound will be divided into 2 with half the wound being treated with the NOx dressing and the other half with standard of care |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOx dressingThe NOx dressing should be changed at least every 2 days. | Device | SPT Burn Wound, SPT graft donor site |
| Standard of CareDressing changed as per normal clinical practice | Device | SPT Burn Wound, SPT graft donor site |
Primary outcome
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
Time frame: From randomisation and first application of the dressing, patients are assessed every 2 days until 95% epithelialisation occurs
4 secondary outcomes
Assessment of healing by blinded evaluation of photographs
Time frame: 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
Time frame: 3 and 12 months post healing
Colonisation of wounds
Time frame: Baseline and every 2 days therafter until 95% epithelialisation occurs
Tolerance and safety of the dressing
Time frame: Baseline and every 2 days thereafter
Results and safety
The study was stopped early (reason given: The study was paused initially pending a review of the study design. The decision was then taken not to resume the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Stewart, PhD principal investigator
Queen Mary University London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NOx dressing in people with Superficial Partial Thickness Burn and Skin Graft; Complications, run by Edixomed Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was paused initially pending a review of the study design. The decision was then taken not to resume the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From randomisation and first application of the dressing, patients are assessed every 2 days until 95% epithelialisation occurs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.