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

Superficial Partial Thickness Burn Clinical Trial

— ProNOx2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01983085
• Other study ID #: EDX 120
• Status: Terminated
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: May 2014

Study information

• Verified date: April 2021
• Source: Edixomed Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Graft; Complications
• Superficial Partial Thickness Burn

Intervention

Device:
• NOx dressing
The NOx dressing should be changed at least every 2 days.
• Standard of Care
Dressing changed as per normal clinical practice

Locations

Country	Name	City	State
United Kingdom	St Andrew's Centre for Plastic Surgery and Burns, Broomfield Hospital	Chelmsford	Essex
United Kingdom	Canniesburn Regional Plastic Surgery and Burns Unit, Glasgow Royal Infirmary,	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Edixomed Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of healing by blinded evaluation of photographs		Every 2 days from baseline until 95% epithelialisation occurs
Secondary	Cosmetic Outcomes measured using both the Vancouver Scar Scale and the Patient Observer Scar Assessment Scale		3 and 12 months post healing
Secondary	Colonisation of wounds	Wound swabs will be taken at every patient visit, every 2 days, until 95% epithelialisation occurs.	Baseline and every 2 days therafter until 95% epithelialisation occurs
Secondary	Tolerance and safety of the dressing	Assessment of reported adverse events	Baseline and every 2 days thereafter