Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TGE - W01
Study information
Scientific title
A preliminary single-centre, randomised, comparative study of the Eakin wound dressing in the management of superficial/partial thickness wounds
Acronym
Study hypothesis
Eakin wound dressing is effective and safe for use on humans with superficial/partial thickness wounds.
Ethics approval
Not provided at time of registration
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Wounds
Intervention
Eakin wound dressing will be trialled against a leading hydrocolloid wound dressing for a period of 5 weeks or until the wound has healed. Dressings will be changed every 4 days.
Intervention type
Drug
Phase
Not Specified
Drug names
Eakin wound dressing
Primary outcome measures
Confirmation of the clinical efficacy and safety of Eakin wound dressing when used in the treatment of superficial/partial thickness wounds. Wound is healed (or reduced in size) over a period of 5 weeks.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2005
Overall trial end date
31/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All patients presenting superficial/partial thickness wounds which could or would normally be treated with a 'hydrocolloid' wound dressing, and who are not precluded by the exclusion criteria below, will be invited to participate in this clinical trial.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 hospital patients
Participant exclusion criteria
Patients will be excluded from the trial under the following circumstances:
1. Wound is >5 cm length or breadth
2. Wound is >0.5 cm depth
3. Wound involving muscle, tendon or bone
4. Wound infection is suspected
5. Where informed consent is withheld
6. Where patients are unable to give informed consent due to legal incompetence, unless informed consent is available from a responsible relative or guardian
7. Where, in the physician's opinion, inclusion in the trial is not advised
Recruitment start date
01/10/2005
Recruitment end date
31/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Group of Hospitals Trust
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
TG Eakin Limited (UK)
Sponsor details
15 Ballystockart Road
Comber
BT23 5QY
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Full cost of trial will be funded by TG Eakin Limited (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary