Clinical trial NCT01983085: Nitric Oxide Generating Gel Dressing in Patients With Superficial Partial Thickness Wounds
Official title: ProNOx 2 - A Clinical Study of Superficial Partial Thickness Wound Treatment With an Oxides of Nitrogen Generating Gel Dressing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Superficial Partial Thickness Burn
Skin Graft; Complications
Keywords: Nitric Oxide Dressing
Nitric oxide
Superficial partial thickness wound
Burns
Skin graft donor sites
Improved healing
Vasodilation
Angiogenesis
Anti-microbial
Lead sponsor: Edixomed Ltd
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: From randomisation and first application of the dressing, patients are assessed every 2 days until 95% epithelialisation occurs
Secondary outcomes:
measure: Assessment of healing by blinded evaluation of photographs
timeFrame: Every 2 days from baseline until 95% epithelialisation occurs
measure: Cosmetic Outcomes measured using both the Vancouver Scar Scale and the Patient Observer Scar Assessment Scale
timeFrame: 3 and 12 months post healing
measure: Colonisation of wounds
timeFrame: Baseline and every 2 days therafter until 95% epithelialisation occurs
measure: Tolerance and safety of the dressing
timeFrame: Baseline and every 2 days thereafter
Other outcomes:
Locations:
city: Chelmsford
country: United Kingdom
facility: St Andrew's Centre for Plastic Surgery and Burns, Broomfield Hospital
state: Essex
city: Glasgow
country: United Kingdom
facility: Canniesburn Regional Plastic Surgery and Burns Unit, Glasgow Royal Infirmary,
Study officials:
affiliation: Queen Mary University London
name: Joanne Stewart, PhD
role: PRINCIPAL_INVESTIGATOR
References: