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 |
| Protocol serial number | N0207182916 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Royal Liverpool and Broadgreen University Hospitals Trust (UK), NHS R&D Support Funding |
- 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
Scientific
Orthopaedic Directorate
RLUH
Prescott Street
Liverpool
L7 8XP
United Kingdom
| Phone | +44 0151 706 3440 |
|---|---|
| Christopher.Walker@rlbuht.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Time and patient discomfort to remove sutures from the surgical wound. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Orthopaedic Directorate
Liverpool
L7 8XP
United Kingdom
L7 8XP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |