A preliminary single-centre, randomised, comparative study of the Eakin wound dressing in the management of superficial/partial thickness wounds

ISRCTN ISRCTN60271166
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

Royal Group of Hospitals Trust
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Study information

Study designSingle-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA preliminary single-centre, randomised, comparative study of the Eakin wound dressing in the management of superficial/partial thickness wounds
Study objectivesEakin 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) studiedWounds
InterventionEakin 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Eakin wound dressing
Primary outcome measureConfirmation 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 measuresNot provided at time of registration
Overall study start date01/10/2005
Completion date31/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 hospital patients
Key inclusion criteriaAll 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 criteriaPatients 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 enrolment01/10/2005
Date of final enrolment31/01/2006

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Royal Group of Hospitals Trust
Belfast
BT12 6BA
United Kingdom

Sponsor information

TG Eakin Limited (UK)
Industry

15 Ballystockart Road
Comber
BT23 5QY
United Kingdom

Website http://www.eakin.co.uk/home.asp

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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

07/03/2017: No publications found in PubMed, verifying study status with principal investigator