Nitric Oxide Generating Gel Dressing in Patients With Superficial Partial Thickness Wounds (ProNOx2)

Edixomed

Status and phase: Terminated; Phase 2

Conditions: Superficial Partial Thickness Burn; Skin Graft; Complications

Treatments: Device: NOx dressing; Device: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01983085

EDX 120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

SPT Burn Wound

Other group

Description:

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

Treatment:

Device: NOx dressing

Device: Standard of Care

SPT graft donor site

Other group

Description:

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

Treatment:

Device: NOx dressing

Device: Standard of Care