A preliminary single-centre, randomised, comparative study of the Eakin wound dressing in the management of superficial/partial thickness wounds
ISRCTN | ISRCTN60271166 |
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DOI | https://doi.org/10.1186/ISRCTN60271166 |
Secondary identifying numbers | TGE - W01 |
- Submission date
- 11/05/2005
- Registration date
- 15/06/2005
- Last edited
- 07/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Denis Harkin
Scientific
Scientific
Royal Group of Hospitals Trust
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Study information
Study design | Single-centre randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A preliminary single-centre, randomised, comparative study of the Eakin wound dressing in the management of superficial/partial thickness wounds |
Study objectives | Eakin wound dressing is effective and safe for use on humans with superficial/partial thickness wounds. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Eakin wound dressing |
Primary outcome measure | 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 study start date | 01/10/2005 |
Completion date | 31/01/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 40 hospital patients |
Key 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. |
Key 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 |
Date of first enrolment | 01/10/2005 |
Date of final enrolment | 31/01/2006 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Royal Group of Hospitals Trust
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
TG Eakin Limited (UK)
Industry
Industry
15 Ballystockart Road
Comber
BT23 5QY
United Kingdom
Website | http://www.eakin.co.uk/home.asp |
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Funders
Funder type
Industry
Full cost of trial will be funded by TG Eakin Limited (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
07/03/2017: No publications found in PubMed, verifying study status with principal investigator