Does the use of sutures reduce the wound complication rate following surgery in hip fractures?
| ISRCTN | ISRCTN12692904 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12692904 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Medway Maritime Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 13/05/2020
- Registration date
- 18/01/2021
- Last edited
- 18/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The femoral neck is the most common location for a hip fracture. About 75,000 femoral neck are treated by the NHS every year. The reported incidence of wound complications is around 10%. Recent research has suggested an increased risk of infection. The aim of this study is to investigate wound healing and complications related to surgery following neck of femur fracture in the elderly. The aim is to compare wound problems and infection following two different methods of skin closure: subcuticular monocryl suture or metal clips.
Who can participate?
All patients admitted with intracapsular or extracapsular neck of femur fracture and undergoing either hemiarthroplasty or Dynamic Hip Screw operation and with mental capacity.
What does the study involve?
Participants are randomly allocated to be treated with either subcuticular monocryl suture or metal clips for skin closure after surgery. Wound problems, infection and duration of surgery are compared.
What are the possible benefits and risks of participating?
The possible benefits are that the wound healing process can be closely monitored associated with the standard wound closure methods used (sutures and metal clips). The researchers do not anticipate any risks as such.
Where is the study run from?
Medway Maritime Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2012 to January 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mr Rajesh Bawale, rajesh.bawale@nhs.net
Prof. Bijayendra Singh, bijayendra.singh@nhs.net
Contact information
Scientific
Medway Maritime hospital
Windmill road
Gillingham
Gillingham
ME7 5NY
United Kingdom
 ORCID ID |
0000-0002-3127-0105 |
|---|---|
| Phone | +44 (0)1634 830000 |
| rajesh.bawale@nhs.net |
Scientific
Medway Maritime hospital
Windmill road
Gillingham
Gillingham
ME7 5NY
United Kingdom
| Phone | +44 (0)1634 830000 |
|---|---|
| bijayendra.singh@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective single-centre randomized parallel trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Use of sutures reduces wound complication rate following surgery in hip fractures - a prospective randomised trial |
| Study objectives | Orthopaedic surgical site infections are one of the most important and often devastating post-operative complications and can prolong hospital stay by a few days to weeks. Hence choosing the appropriate method of wound closure to prevent wound complications is vital. There is no consensus in the literature as to which skin closure method is better. The aim of this study is to compare the wound problems and infection following two different methods of skin closure: subcuicular sutures and metal clips. |
| Ethics approval(s) | Approved 27/02/2012, NRES Committee London - Queen Square (Room 4W/12, 4th Floor West, Charing Cross Hospital, Fulham, Palace Road, London, W6 8RF, UK; +44 (0)20 3311 7287; queensquare.rec@hra.nhs.uk), REC ref: 11/LO/1452 |
| Health condition(s) or problem(s) studied | Recovery from surgery for fractured neck of femur |
| Intervention | The randomisation and the allocation are done by using sequentially numbered opaque and unmarked sealed envelopes. After completion of the hip hemiarthroplasty and dynamic hip screw surgery, the surgical wounds are closed with either metal clips or the 3-0 absorbable poliglecaprone as allocated following randomisation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Wound problems measured using Singh’s Wound Score (SWS) at days 2, 5, 7, 10 and 14 days |
| Key secondary outcome measure(s) |
Duration of surgery (min) measured using patient records at the end of surgery |
| Completion date | 15/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 500 |
| Total final enrolment | 526 |
| Key inclusion criteria | 1. Admitted with intracapsular or extracapsular neck of femur fracture 2. Undergoing either hemiarthroplasty or dyanmic hip screw operation 3. Mental capacity |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 24/07/2012 |
| Date of final enrolment | 04/03/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Gillingham
Gillingham
ME7 5NY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. B Singh (bijayendra.singh@nhs.net) and Mr R Bawale (rajesh.bawale@nhs.net). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/01/2021: Trial's existence confirmed by NRES Committee London - Queen Square.
