A randomised prospective study to compare the use of skin staples versus Dermabond tissue adhesive in the management of wound healing in patients undergoing thyroid and parathyroid surgery: a pilot study

ISRCTN ISRCTN25938172
DOI https://doi.org/10.1186/ISRCTN25938172
Secondary identifying numbers N0084144554
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
12/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr P Moore
Scientific

Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesWhich method, the use of skin staples or Dermabond is most clinically and cost effective and acceptable to patients undergoing thyroid and parathyroid surgery.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Thyroid and parathyroid
InterventionThis study looks at the performance of skin adhesive Dermabond against the standard method of skin closure I.e. skin staples in elective thyroid or parathyroid surgery. If the result of the pilot study show the skin adhesive to be comparable or possibly superior to the staples then it will provide information for the design of a larger study, which will allow thorough statistical analysis of the performance of each method of skin closure.
Intervention typeProcedure/Surgery
Primary outcome measurePatients undergoing elective thyroid or parathyroid surgery under the care of Mr Moore will be invited to take part in the study until a cohort of 30 patients has been recruited.
Secondary outcome measuresNot provided at time of registration
Overall study start date30/11/2002
Completion date30/11/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants30
Key inclusion criteriaPatients who are over the age of 18 years and undergoing thyroid or parathyroid surgery, have no known allergy to the products used in this study.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment30/11/2002
Date of final enrolment30/11/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2007 Yes No