| Source of record | UK Trials |
| ISRCTN | ISRCTN33707890 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0207182916 |
| Public title | 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 |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Surgery: Foot and ankle |
| Study hypothesis | To study if closure of a surgical wound in the foot or ankle, using a new technique is faster and more comfortable. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Sixty eligible adult patients undergoing foot or ankle elective surgery. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 01/03/2006 |
| Anticipated end date | 01/03/2008 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | 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. |
| Primary outcome measure(s) | Time and patient discomfort to remove sutures from the surgical wound. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Royal Liverpool and Broadgreen University Hospitals Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Christopher Walker |
| Contact details | Orthopaedic Directorate
RLUH
Prescott Street
Liverpool
United Kingdom
L7 8XP |
| Contact telephone | +44 0151 706 3440 |
| Contact fax | +44 |
| Contact email | Christopher.Walker@rlbuht.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN33707890 |
| Date last extracted from ISRCTN register | 17/04/2008 |
