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A realist evaluation of ‘paste’ and ‘dry’ compression bandages

A realist evaluation of ‘paste’ and ‘dry’ compression bandages: The ROSE study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN83184899
Enrollment
40
Registered
2025-03-20
Start date
2025-01-15
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with/without leg ulceration who require compression bandages Nutritional, Metabolic, Endocrine

Interventions

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 coll
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 pro

Sponsors

Newcastle Joint Research Office
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

England, United Kingdom

Contacts

Public ContactFania Pagnamenta
fania.pagnamenta@nhs.net+44 (0)191223145

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026