A realist evaluation of ‘paste’ and ‘dry’ compression bandages
| ISRCTN | ISRCTN83184899 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83184899 |
| IRAS number | 328315 |
| Secondary identifying numbers | 10604 |
- Submission date
- 14/02/2025
- Registration date
- 20/03/2025
- Last edited
- 20/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Compression bandages are used in the treatment of leg ulceration. A leg ulcer develops when blood vessels are not working as they should; they are painful, distressing and have a considerable impact on quality of life. They require frequent dressing changes, but with correct treatment can heal within three months. Evidence that compression is the gold standard to heal leg ulceration exists, but comparative data between different brands of compression bandages does not. Selection of a compression system is often based on nurses’ preference, based on their acquired knowledge and skills of product application. This study aims to understand when, for whom, and in what circumstances two very different product types should be selected (paste or dry) to treat individual patient’s lower limbs. Patients have been the primary inspiration for this project. They often report that they are unable to tolerate compression bandages and when questioned in more detail, it appears that different systems have not been considered.
Who can participate?
Adult patients who require bilateral compression bandages (registered with a Newcastle upon Tyne GP) will be selected from the caseload of District Nurses and Ambulatory Clinics.
What does the study involve?
This study will use a research technique called ‘realist evaluation’, which acknowledges that leg ulcer care is complex, and is undertaken in a complex health care system. The process commences with listing what we think is happening (initial theories) and refining this through the analysis until the most plausible explanation is found.
The study is divided into two concurrent parts:
1. Opinions on the ease of application will be sought from Community Nurses and District Nurses who are applying the compression bandages to the recruited patients
2. Opinions on comfort will be sought from the recruited patients
What are the possible benefits and risks of participating?
Participants will be offered to try two different types of compression bandages and at the end of the study, choose the one they like the most.
Risks not provided at registration.
Where is the study run from?
The Newcastle upon Tyne Hospitals NHS Foundation Trust, UK
When is the study starting and how long is it expected to run for?
December 2024 to April 2026
Who is funding the study?
OVIK Health LLC
Who is the main contact?
Dr Fania Pagnamenta, fania.pagnamenta@nhs.net
Contact information
Public, Scientific, Principal Investigator
c/o Royal Victoria Hospital
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
 ORCID ID |
0000-0002-5831-5799 |
|---|---|
| Phone | +44 (0)191223145 |
| fania.pagnamenta@nhs.net |
Study information
| Study design | Realist evaluation study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Community, Home, Other therapist office |
| Study type | Quality of life |
| Participant information sheet | 46849_PIS_Patients and Carers_V2.2_17Jan2024.pdf |
| Scientific title | A realist evaluation of ‘paste’ and ‘dry’ compression bandages: The ROSE study |
| Study acronym | ROSE |
| Study objectives | To understand when, for whom, and in what circumstances two different types of compression bandages are selected; to add to the body of knowledge that pertains to leg ulceration care and guide staff in selecting the appropriate compression bandage for each patient. |
| Ethics approval(s) |
Approved 27/01/2025, South West - Central Bristol Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)207 104 8197, (0)207 104 8269, (0)207 104 8194; centralbristol.rec@hra.nhs.uk), ref: 23/SW/0141 |
| Health condition(s) or problem(s) studied | Patients with/without leg ulceration who require compression bandages |
| Intervention | This is a non-interventional study. The research nurse will visit the participant at the place where they normally have their wound dressed, for example at their home or the ambulatory clinic, to collect information on the medical history of the participant's legs. At this visit, participants will be asked to complete a questionnaire on their general quality of life. The research nurse will ask questions about pain and how itchy their legs are. The research nurse will visit the participant on the first day of the study (Day 1), after one week (Week 1), after four weeks (Week 4) and after eight weeks (Week 8) which is the last day of the study. If they usually have their wound dressed at home, the research nurse will visit at home during the study. On each visit, the research nurse will ask them to complete questionnaires on how much pain they have and how itchy their legs are. The research nurse will collect information on the wound at each visit and take photographs. Their legs will be bandaged using two types of bandages. One leg will be bandaged using a dry bandage and one leg will be bandaged using a wet bandage. A wet bandage is a bandage that has either zinc or calamine on the first layer; a dry bandage has no wet component. Both systems are currently used, but it is unknown which system works best under which circumstances. Which leg receives what treatment will be decided using a process called ‘randomisation’, which means that each leg will have the same chance of being treated either with a wet bandage or a dry bandage. The Research Nurse will open a sealed envelope which will tell her what type of bandage to apply to the left leg and what bandage to apply to the right leg. The Research Nurse will have no prior knowledge of the instructions contained in the envelope. |
| Intervention type | Other |
| Primary outcome measure | This study aims to provide explanations of when, for whom, and in what circumstances two different types of compression bandages are selected for the treatment of lower limb ulceration. The premise is that all systems under review in this study work equally well, but it is unclear which system works best in the right patient, at the right time and in the hand of the right clinician. These data will be collected by the Research Nurse using questionnaires during study visits on the first day of the study (Day 1), after one week (Week 1), after four weeks (Week 4) and after eight weeks (Week 8). Theoretical framework A realist evaluation will be undertaken, which contends that intervention impacts (Outcomes) occur when certain causal processes (Mechanisms) are ‘triggered’ in the most favourable environments (Contexts). CMO configurations are used as explanatory theories that are refined and tested with empirical data. A key element in realist synthesis is the formulation of ‘educated guesses’ theories, which are explanatory statements based on the available literature, in addition to the researcher team's clinical expertise and experience. An initial meeting will take place before the beginning of the study with 1 District Nurse, 1 TVN (community); 1 Registered Nurse from the Ambulatory Clinics and the research team to develop these initial statements and they will be refined by the research team into Initial Programme Theories (IPTs). These IPTs will be tested and refined with the data collected below. |
| Secondary outcome measures | The secondary objectives are to add to the body of knowledge that pertains to leg ulceration care and guide staff to select the right compression bandage for each patient. These data will be collected by the Research Nurse using questionnaires during study visits on the first day of the study (Day 1), after one week (Week 1), after four weeks (Week 4) and after eight weeks (Week 8). |
| Overall study start date | 01/12/2024 |
| Completion date | 01/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Age ≥ 18 years of age 2. Patient living in Newcastle upon Tyne, with a Newcastle GP 3. Patients with existing bilateral leg ulceration or legs that require compression bandages to prevent ulcer (re)-occurrence 4. Patients with new bilateral leg ulceration or legs that require compression bandages to prevent ulcer (re)-occurrence |
| Key exclusion criteria | 1. Patients younger than 18 years of age 2. Patients in nursing homes 3. Patients with leg ulcerations that do not necessitate compression bandages. 4. Patients with leg ulcerations that require a specific type of compression bandages (i.e. lymphoedema) |
| Date of first enrolment | 15/01/2025 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Hospital/treatment centre
A partnership between The Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, c/o Regent Point
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)1912824519 |
|---|---|
| emily.wells5@nhs.net |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Findings will be introduced in NuTH clinical practice, advancing knowledge translation. Impact will be maximised regionally and nationally, through the following presentation: 1. 2-3 international clinical conferences (2025) 2. Regional wound care networks and the Shelford Tissue Viability Group 3. 1-2 clinical academic journal articles. Open access fees for these papers have been included in the proposed funding to ensure they reach a wide audience and to ensure transparency of the research. |
| IPD sharing plan | The datasets generated during and /or analysed during the current study are not expected to be made available due to the confidentiality of treatment. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.2 | 17/01/2024 | 17/02/2025 | No | Yes |
| Participant information sheet | version 2.2 | 17/01/2024 | 17/02/2025 | No | Yes |
| Protocol file | version 2.3 | 18/12/2024 | 17/02/2025 | No | No |
Additional files
Editorial Notes
14/02/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
