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

April 12, 2021 updated by: Edixomed Ltd

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G4 0SF
        • Canniesburn Regional Plastic Surgery and Burns Unit, Glasgow Royal Infirmary,
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • St Andrew's Centre for Plastic Surgery and Burns, Broomfield Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From randomisation and first application of the dressing, patients are assessed every 2 days until 95% epithelialisation occurs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of healing by blinded evaluation of photographs
Time Frame: Every 2 days from baseline until 95% epithelialisation occurs
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
3 and 12 months post healing
Colonisation of wounds
Time Frame: 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.
Baseline and every 2 days therafter until 95% epithelialisation occurs
Tolerance and safety of the dressing
Time Frame: Baseline and every 2 days thereafter
Assessment of reported adverse events
Baseline and every 2 days thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edixomed Ltd

Investigators

  • Principal Investigator: Joanne Stewart, PhD, Queen Mary University London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EDX 120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Superficial Partial Thickness Burn

Clinical Trials on NOx dressing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe