Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr P Moore

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17394707

Publication citations

  1. 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.

Additional files

Editorial Notes