Overview

This trial is active, not recruiting.

Conditions superficial partial thickness burn, skin graft; complications
Treatments nox dressing, standard of care
Phase phase 2
Sponsor Edixomed Ltd
Start date September 2013
End date October 2016
Trial size 160 participants
Trial identifier NCT01983085, EDX 120

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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
nox dressing
The NOx dressing should be changed at least every 2 days.
standard of care
Dressing changed as per normal clinical practice
(Other)
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
nox dressing
The NOx dressing should be changed at least every 2 days.
standard of care
Dressing changed as per normal clinical practice

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
time frame: 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
time frame: 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
Colonisation of wounds
time frame: Baseline and every 2 days therafter until 95% epithelialisation occurs
Tolerance and safety of the dressing
time frame: Baseline and every 2 days thereafter

Eligibility Criteria

Male or female participants at least 1 year old.

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.

Additional Information

Official title ProNOx 2 - A Clinical Study of Superficial Partial Thickness Wound Treatment With an Oxides of Nitrogen Generating Gel Dressing
Principal investigator Joanne Stewart, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Edixomed Ltd.