Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084144554
Study information
Scientific title
Acronym
Study hypothesis
Which 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Thyroid and parathyroid
Intervention
This 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 type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
Patients 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 measures
Not provided at time of registration
Overall trial start date
30/11/2002
Overall trial end date
30/11/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/11/2002
Recruitment end date
30/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17394707
Publication citations
-
Results
Ridgway DM, Mahmood F, Moore L, Bramley D, Moore PJ, A blinded, randomised, controlled trial of stapled versus tissue glue closure of neck surgery incisions., Ann R Coll Surg Engl, 2007, 89, 3, 242-246, doi: 10.1308/003588407X179062.