Nitric Oxide Generating Gel Dressing in Patients With Superficial Partial Thickness Wounds
NCT ID: NCT01983085
Last Updated: 2021-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
13 participants
INTERVENTIONAL
2013-09-30
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
NOx dressing
The NOx dressing should be changed at least every 2 days.
Standard of Care
Dressing changed as per normal clinical practice
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
NOx dressing
The NOx dressing should be changed at least every 2 days.
Standard of Care
Dressing changed as per normal clinical practice
Interventions
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NOx dressing
The NOx dressing should be changed at least every 2 days.
Standard of Care
Dressing changed as per normal clinical practice
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
ALL
No
Sponsors
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Edixomed Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Joanne Stewart, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University London
Locations
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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, , United Kingdom
Countries
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Other Identifiers
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EDX 120
Identifier Type: -
Identifier Source: org_study_id
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