Does the use of sutures reduce the wound complication rate following surgery in hip fractures?

ISRCTN	ISRCTN12692904
DOI	https://doi.org/10.1186/ISRCTN12692904

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Mr Rajesh Bawale
Scientific

Medway Maritime hospital
Windmill road
Gillingham
Gillingham
ME7 5NY
United Kingdom

ORCID ID	0000-0002-3127-0105
Phone	+44 (0)1634 830000
Email	rajesh.bawale@nhs.net

Prof Bijayendra Singh
Scientific

Medway Maritime hospital
Windmill road
Gillingham
Gillingham
ME7 5NY
United Kingdom

Phone	+44 (0)1634 830000
Email	bijayendra.singh@nhs.net

Study information

Study design	Prospective single-centre randomized parallel trial
Primary study design	Interventional
Secondary study design	Randomised parallel 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	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	1. Wound problems measured using Singh’s Wound Score (SWS) at days 2, 5, 7, 10 and 14 days 2. Wound infection measured using Singh’s Wound Score (SWS) at days 7,10 and 14 days
Secondary outcome measures	Duration of surgery (min) measured using patient records at the end of surgery
Overall study start date	05/04/2012
Completion date	15/01/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Medway Maritime Hospital

Windmill Road
Gillingham
Gillingham
ME7 5NY
United Kingdom

Sponsor information

Medway Maritime Hospital
Hospital/treatment centre

c/o Dr Edyta McCallum
Windmill Road
Gillingham
ME7 5NY
England
United Kingdom

Phone	+44 (0)1634 830000 Extn 3030
Email	edyta.mccallum@nhs.net
"ROR"	https://ror.org/02380m508

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/02/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	1. Study protocol and statistical analysis plan are available on request 2. Planned publication in a high-impact peer-reviewed journal
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).

Editorial Notes

18/01/2021: Trial's existence confirmed by NRES Committee London - Queen Square.