Prospective randomised trial comparing traditional suture technique with the sliding loop suture technique in the closure of surgical wounds in the foot and ankle area

ISRCTN	ISRCTN33707890
DOI	https://doi.org/10.1186/ISRCTN33707890
Secondary identifying numbers	N0207182916

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 15/02/2012

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 Christopher Walker
Scientific

Orthopaedic Directorate
RLUH
Prescott Street
Liverpool
L7 8XP
United Kingdom

Phone	+44 0151 706 3440
Email	Christopher.Walker@rlbuht.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	To study if closure of a surgical wound in the foot or ankle, using a new technique is faster and more comfortable.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Time and patient discomfort to remove sutures from the surgical wound.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/03/2006
Completion date	01/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	Sixty eligible adult patients undergoing foot or ankle elective surgery.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/03/2006
Date of final enrolment	01/03/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Orthopaedic Directorate

Liverpool
L7 8XP
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, 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

Royal Liverpool and Broadgreen University Hospitals Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2003		Yes	No