Contact information
Type
Scientific
Primary contact
Mr Christopher Walker
ORCID ID
Contact details
Orthopaedic Directorate
RLUH
Prescott Street
Liverpool
L7 8XP
United Kingdom
+44 0151 706 3440
Christopher.Walker@rlbuht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0207182916
Study information
Scientific title
Acronym
Study hypothesis
To study if closure of a surgical wound in the foot or ankle, using a new technique is faster and more comfortable.
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
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Foot and ankle
Intervention
Half of the wounds length will be sutured using the traditional closing technique (control part) and the other half using the traction loop technique. The sutures will be removed in the outpatients department by an experienced nurse clinician. Prior to suture removal a junior nurse will open an envelope to indicate the part of the wound from where the suture removal will start. A junior doctor who will have no participation in the suture removal process will prepare the envelopes. A curtain will be placed, to ensure the patient has no visual contact with the wound during suture removal.
A junior staff nurse or nursing student will be timing suture removal for each part of the wound. Pain during suture removal will be recorded using a 10 point visual analogue scale. Immediately after each part of the wound has been dealt with, patients will be recording their pain, using a specially designed form, without any visual contact between patients and the nurse clinician.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Time and patient discomfort to remove sutures from the surgical wound.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2006
Overall trial end date
01/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Sixty eligible adult patients undergoing foot or ankle elective surgery.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2006
Recruitment end date
01/03/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Orthopaedic Directorate
Liverpool
L7 8XP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
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
Royal Liverpool and Broadgreen University Hospitals Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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
1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12533364
Publication citations
-
Results
Gandham SG, Menon D, Prospective randomised trial comparing traditional suture technique with the dynamic sliding loop suture technique in the closure of skin lacerations., Emerg Med J, 2003, 20, 1, 33-36.