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

Sponsor

Edixomed Ltd (Industry)

Overall Status

Terminated

CT.gov ID

NCT01983085

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Superficial Partial Thickness Burn Skin Graft; Complications	Device: NOx dressing Device: Standard of Care	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

ProNOx 2 - A Clinical Study of Superficial Partial Thickness Wound Treatment With an Oxides of Nitrogen Generating Gel Dressing

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: SPT Burn Wound 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	Device: NOx dressing The NOx dressing should be changed at least every 2 days. Device: Standard of Care Dressing changed as per normal clinical practice
Other: SPT graft donor site 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	Device: NOx dressing The NOx dressing should be changed at least every 2 days. Device: Standard of Care Dressing changed as per normal clinical practice

Arm

Intervention/Treatment

Other: SPT Burn Wound

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

Device: NOx dressing

The NOx dressing should be changed at least every 2 days.

Device: Standard of Care

Dressing changed as per normal clinical practice

Other: SPT graft donor site

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

Device: NOx dressing

The NOx dressing should be changed at least every 2 days.

Device: Standard of Care

Dressing changed as per normal clinical practice

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of healing by blinded evaluation of photographs [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 [3 and 12 months post healing]
Colonisation of wounds [Baseline and every 2 days therafter until 95% epithelialisation occurs]
Wound swabs will be taken at every patient visit, every 2 days, until 95% epithelialisation occurs.
Tolerance and safety of the dressing [Baseline and every 2 days thereafter]
Assessment of reported adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Andrew's Centre for Plastic Surgery and Burns, Broomfield Hospital	Chelmsford	Essex	United Kingdom	CM1 7ET
2	Canniesburn Regional Plastic Surgery and Burns Unit, Glasgow Royal Infirmary,	Glasgow		United Kingdom	G4 0SF