NCT01983085

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

October 30, 2013

Last Update Submit

April 12, 2021

Conditions

Superficial Partial Thickness BurnSkin Graft; Complications

Keywords

Nitric Oxide DressingNitric oxideSuperficial partial thickness woundBurnsSkin graft donor sitesImproved healingVasodilationAngiogenesisAnti-microbial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Tolerance and safety of the dressing

    Baseline and every 2 days thereafter

Study Arms (2)

SPT Burn Wound

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

Device: NOx dressingDevice: Standard of Care

SPT graft donor site

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

Device: NOx dressingDevice: Standard of Care

Interventions

NOx dressingDEVICE

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

SPT Burn WoundSPT graft donor site
Standard of CareDEVICE

Dressing changed as per normal clinical practice

SPT Burn WoundSPT graft donor site

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Andrew's Centre for Plastic Surgery and Burns, Broomfield Hospital

Chelmsford, Essex, CM1 7ET, United Kingdom

Location

Canniesburn Regional Plastic Surgery and Burns Unit, Glasgow Royal Infirmary,

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

BurnsAneurysm

Condition Hierarchy (Ancestors)

Wounds and InjuriesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joanne Stewart, PhD

    Queen Mary University London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 13, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

April 15, 2021

Record last verified: 2021-04

Locations

GB(2)