- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05414916
Pain Relief Strategies for Dressing Change in Chronic Wounds
Pain Relief Strategies for Dressing Change in Chronic Wounds: Qualitative Interview Stage
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Richard Cooper, PhD
- Phone Number: +44 114 222 0768
- Email: richard.cooper@sheffield.ac.uk
Study Contact Backup
- Name: Andy Kirkcaldy, BA, MSc
- Phone Number: +44 114 222 0741
- Email: A.J.Kirkcaldy@sheffield.ac.uk
Study Locations
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Yorkshire
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Goole, Yorkshire, United Kingdom, DN14 6RU
- Recruiting
- Goole Health Centre
-
Contact:
- Jo Panizales
- Email: jo.panizales@nhs.net
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Rotherham, Yorkshire, United Kingdom, S65 1DA
- Recruiting
- Clifton Medical Centre
-
Contact:
- Dale Carter
- Email: dale.carter@nhs.net
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 6 months
|
experiences and strategies will be explored and captured from qualitative data collected from semi-structured interviews
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Cooper, PhD, University of Sheffield
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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