Can we test antimicrobial stitches in surgery for hand and wrist injuries? A feasibility study
| ISRCTN | ISRCTN10771059 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10771059 |
| IRAS number | 292544 |
| Secondary identifying numbers | CPMS 50951, NIHR301793, IRAS 292544 |
- Submission date
- 31/01/2022
- Registration date
- 10/02/2022
- Last edited
- 28/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Hand and wrist injuries, also known as hand and wrist ‘trauma’, account for 1 in 5 emergency hospital visits. Every year, over 5 million people in the UK are affected, from young working people to the elderly. The hand and wrist are important in daily life and for earning a living. Many injuries need surgery and there is a risk of infection afterwards. The risk is unknown, but it might be as high as 1 in 4 people. Also, little is known about the knock-on effects of infection, which might be severe, including amputation. At the end of surgery for these injuries, the skin is closed using stitches. Specially coated stitches, known as ‘antimicrobial stitches’, might reduce infection in the wound by killing nearby bacteria. Preventing infection after surgery could improve recovery, regaining hand and wrist function sooner, and could reduce NHS costs. We want to test the usefulness of these antimicrobial stitches with a clinical trial in the NHS. This small-scale study will look at antimicrobial stitches and infection. In this study, consenting participants with hand and wrist injuries from three hospitals in England will be allocated, by chance, into two groups. One group will get antimicrobial stitches during their surgery and one group will get normal stitches. There will be no other differences between the two groups. The purpose of this small-scale study is to test out the information we give to people and to see if people would be happy to take part. The practicalities of measuring infection after surgery will also be tested. The results will allow us to determine if we can conduct a larger study to see if the antimicrobial stitches do reduce infection in people having surgery for hand and wrist injuries.
Who can participate?
Adults 18 and older with injuries to the hand and/or wrist that requires surgery that involves stitching to repair the injury
What does the study involve?
Participants will either receive standard stitches or antimicrobial stitches, completely by chance. They will not know which ones they have received. Participants will be asked to fill in questionnaires before their operation, then at 30 days, 90 days and 6 months after their operation. All of the questionnaires are electronic and will be sent by email and/or SMS message. They can be completed on a computer, tablet or smartphone.
What are the possible benefits and risks of participating?
Participants will be contributing to our understanding of new technologies by engaging. This will help all patients in the NHS who need surgery. There are no significant risks that are directly related to the study. Some people may have a reaction to the material in the antimicrobial stitches, but this is extremely rare. Both types of stitches are currently in use in the NHS.
Where is the study run from?
The study is run from the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) at the University of Oxford (UK)
When is the study starting and how long is it expected to run for?
October 2020 to June 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Royal College of Surgeons of England
The British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS)
Who is the main contact?
Dr Justin Wormald, justin.wormald@sjc.ox.ac.uk
Contact information
Scientific
Kadoorie Centre
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0001-6197-4093 |
|---|---|
| Phone | +44 7463982263 |
| justin.wormald@ndorms.ox.ac.uk |
Study information
| Study design | Interventional randomized 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 to request a patient information sheet |
| Scientific title | Hand and Wrist Trauma: Antimicrobials and Infection (HAWAII) Feasibility Study – A multi-centre feasibility study of antimicrobial sutures |
| Study acronym | HAWAII |
| Study objectives | Is it possible to perform a randomised clinical trial of antimicrobial sutures versus standard sutures to determine whether they reduce risk of surgical site infection in adults after surgery for hand and wrist trauma? |
| Ethics approval(s) | Approved 11/11/2021, South Central - Oxford C Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 207 104 8256; oxfordc.rec@hra.nhs.uk), ref: 21/SC/0334 |
| Health condition(s) or problem(s) studied | Complications of surgical care following injuries to the wrist and hand |
| Intervention | Antimicrobial sutures. Standard sutures. Randomisation: Those patients who consent to take part in the trial will have their treatment allocated using a secure, centralised, online randomisation service. Randomisation will be on a 1:1 basis, stratified by centre, and age of the patient and will be performed by the local clinical team immediately prior to wound closure. Baseline data collection. The local clinical team or research nurse will enter baseline clinical information onto the CRF once a participant has been recruited. The participant will be asked to complete baseline questionnaires. Follow-up: 30 days. Participants will receive an email/text invitation to complete the outcome measures at 30 days. Follow-up: 90 days. Participants will receive an email/text invitation to complete the outcome measures at 90 days. Follow-up: 6 months. Participants will receive an email/text invitation to complete the outcome measures at 6 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured using patient records at the end of the study: 1. Number of eligible patients that are randomised to either the intervention or control 2. Number of eligible patients 3. Number of patients that consent to be included in the study 4. Number of participants with completed outcome measures |
| Secondary outcome measures | 1. Surgical site infection (SSI) measured using the Bluebelle Wound Healing Questionnaire (WHQ) at 30 days and 90 days post- surgery 2. Hand function measured using the Patient Evaluation Measure (PEM) Part 2 and PROMIS Upper Extremity (PROMIS UE) at 30 days, 90 days and 6 months post-surgery 3. Health-related quality of life (HRQoL)measured using the EQ-5D-5L at 30 days, 90 days and 6 months post-surgery 4. Return to work measured using a return to work questionnaire 90 days and 6 months post- surgery |
| Overall study start date | 05/10/2020 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 116; UK Sample Size: 116 |
| Total final enrolment | 116 |
| Key inclusion criteria | Adults aged 18 years and above undergoing hand and wrist trauma surgery requiring sutures and able and willing to provide informed consent. |
| Key exclusion criteria | 1. Allergic to triclosan (active coating in antimicrobial sutures). 2. Infected wounds. 3. Wounds not amenable to skin closure with sutures. 4. Nailbed injuries. 5. Unable to complete study procedures, including the completion of a patient questionnaire in English. |
| Date of first enrolment | 10/03/2022 |
| Date of final enrolment | 02/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Headington
Oxford
OX3 9DU
United Kingdom
Whielden Street
Amersham
HP7 0JD
United Kingdom
Truro
TR1 3LJ
United Kingdom
Sponsor information
University/education
University Offices
Oxford
OX1 2JD
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RCS
- Location
- United Kingdom
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | We plan on disseminating the results of HAWAII at national and international surgical conferences and publishing the results in a high-impact, peer reviewed specialty journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/07/2022 | 14/07/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 27/09/2023 | 28/09/2023 | Yes | No |
Editorial Notes
28/09/2023: Publication reference added.
02/12/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 21/02/2022 to 10/03/2022.
2. The recruitment end date was changed from 31/12/2022 to 02/11/2022.
3. The total final enrolment was added.
14/07/2022: Publication reference added.
30/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 03/06/2022 to 31/12/2022.
2. The overall trial end date was changed from 31/03/2023 to 30/06/2023.
31/01/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
