Surgical wounds healing by secondary intention (SWHSI) Surgery
Conditions
Interventions
Observational study.
Quantitative Study:
Participants recruited into the study will be asked to complete a suite of questionnaires and information relating to their wound, general health and impact
Sponsors
Hull University Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years of age with one or more SWHSI at the time of assessment will be eligible for inclusion in the study. 2. SWHSIs will be defined as: 2.1. Surgical wounds intentionally left open to heal by secondary intention within 21 days from the time of operation, or 2.2. Primarily closed surgical wounds that have since dehisced and are being managed thereafter by secondary intention. For dehisced primarily closed wounds, the time of enrolment in the study must be within 7 days of the wound dehiscence. 3. All participants must be capacitous to make decisions about their healthcare and be sufficiently literate in English to engage with the study information and instruments. As this study aims to evaluate the validity of the UK English-language version of the Wound-QoL questionnaire, eligible participants must have an appropriate level of spoken or written English to be reasonably able to complete the test instrument.
Exclusion criteria
Exclusion criteria: 1. Patients who cannot freely consider enrollment in the trial are not eligible to participate in the trial. 2. Patients who cannot communicate in spoken or written English are not eligible for this study as it is a validation of an English-language questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The validity, reliability and responsiveness of Wound-QoL measured using a quantitative psychometric evaluation, guided by the COSMIN guidelines for validation of patient-reported outcome measures, at 3 time points during their postoperative journey - baseline (at the time of recruitment), 2-7 days after the recruitment, and 12-16 weeks after recruitment Validity and reliability are measured by assessing dimensionality, reliability of scales, limits of agreement, measurement error, convergent and discriminative validity and test-retest reliability Responsiveness is measured by assessing correlation relationships between scores at time points 1 and 3 and clinical information with subgroup analysis for healed and unhealed wounds | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Interpretability measured using an assessment of minimal clinically important difference at time point 1 2. Acceptability measured using a visual analogue scale of acceptability at all time points and a qualitative investigation 3. Accessibility measured qualitatively using interviews at 1 time point 4. Usefulness measured qualitatively using interviews at 1 time point | — |
Countries
England, United Kingdom
Contacts
Public ContactMisha Sidapra
Outcome results
None listed