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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05414916
Other study ID # 165104
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 5, 2022
Est. completion date September 30, 2024

Study information

Verified date June 2023
Source University of Sheffield
Contact Richard Cooper, PhD
Phone +44 114 222 0768
Email richard.cooper@sheffield.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A small-scale study using interviews to explore patients', carers' and health care professionals' experience of pain relief strategies currently used in UK practice for dressing change in chronic wounds.


Description:

In 2012/2013, the National Health Service (NHS) managed an estimated 2.2 million adults >18 years of age with a wound, of which 48% were estimated as being chronic. A chronic wound is an open sore in the skin that does not heal, or takes a long time to heal, and frequently comes back. Chronic wounds include pressure ulcers (bed sores), venous (vein-related) leg ulcers, and foot ulcers in people who have diabetes. Pain is a common experience for people living with chronic wounds and can result from the wound itself, treatments for chronic wounds, including dressing changes; or be anticipatory. Pain during dressing change has been reported as the worst part of living with chronic wounds, followed closely by wound cleansing. Furthermore, dried out dressings and adherent products are most likely to cause pain and trauma at dressing changes as is gauze, while products such as hydrogels and soft silicone dressings are least likely. Evidence suggests that supporting the surrounding skin during dressing removal is not considered a priority, despite evidence that many adhesive products may lead to skin stripping and potential skin trauma and pain. There is at present little recent evidence of pain relief strategies that are currently being used in the UK for dressing change in chronic wounds that includes patients', carers' and healthcare professionals' (people who work in the NHS) use and experience of these. This qualitative research will explore providers' and recipients' self-reported experiences of chronic wound care, and explore strategies used to reduce pain at dressing change. It will ask about the perceived success of these strategies from different participant perspectives, along with how pain is assessed. Perceptions of what factors might contribute to pain at dressing change (e.g., dressing and wound type, skill levels) will be captured along with perceptions of what could improve the management of pain at dressing change.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Living with a chronic wound, informally or privately caring for someone with a chronic wound or providing medical care (e.g. dressing change) for someone with a chronic wound - Ability to give informed consent - Aged aged 18 years or above Exclusion Criteria: - Vulnerable patients (e.g. severe mental illness, learning difficulties, dementia, care home residents) - Inability to provide informed consent - Inability to communicate in English - Not living with a chronic wound, informally or privately caring for someone with a chronic wound or providing medical care (e.g. dressing change) for someone with a chronic wound - Under 18 years of age

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Goole Health Centre Goole Yorkshire
United Kingdom Clifton Medical Centre Rotherham Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To identify what strategies have been used by patients, carers and healthcare professionals to reduce or remove pain associated with dressing changes in chronic wounds. experiences and strategies will be explored and captured from qualitative data collected from semi-structured interviews 6 months
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