PainNCT05414916
Pain Relief Strategies for Dressing Change in Chronic Wounds
An observational study of Pain and Chronic Wound, run by University of Sheffield at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Wound
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Apr 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients registered with a GP practice in England who are living with a chronic wound, informal or private carers for people living with a chronic wound and health care professionals (staff nurses, tissue viability specialists) providing primary or secondary medical care for someone with a chronic wound.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Goole Health Centre
Goole, Yorkshire, DN14 6RU
Jo Panizales, jo.panizales@nhs.net
- Recruiting
Clifton Medical Centre
Rotherham, Yorkshire, S65 1DA
Dale Carter, dale.carter@nhs.net
About this study
Official title: Pain Relief Strategies for Dressing Change in Chronic Wounds: Qualitative Interview Stage
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.
Read the 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.
- Conditions
- Pain, Chronic Wound
- Keywords
- Dressing
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start5 Apr 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Cooper, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414916
- Sponsor's protocol ID
- 165104
- Status last verified
- Jun 2023
- First submitted
- 25 May 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief Strategies for Dressing Change in Chronic Wounds: Qualitative Interview Stage
- ClinicalTrials.gov ID
- NCT05414916
- Acronym / sponsor ID
- 165104
- Conditions
- Pain, Chronic Wound
- Keywords
- Dressing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients registered with a GP practice in England who are living with a chronic wound, informal or private carers for people living with a chronic wound and health care professionals (staff nurses, tissue viability specialists) providing primary or secondary medical care for someone with a chronic wound.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Cooper, PhD principal investigator
University of Sheffield
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Chronic Wound, run by University of Sheffield at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Cooper, PhD (+44 114 222 0768, richard.cooper@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.