Dressing-related Experiences and Surgical Site Self-care in Hip and Knee Replacement: an Observational Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBournemouth University
About this trial
The goal of this prospective observational cohort study is to investigate dressing-related experiences and surgical site self-care in patients who are undergoing a total hip or knee replacement. The main objectives of the study are:
* To evaluate patient adherence to the ISWCAP self-care checklist after total hip or knee replacement within an ERAS pathway. * To explore patient-reported outcomes related to the performance and comfort of advanced dressings. * To assess the perceived adequacy and usefulness of post-discharge wound care education. * To identify the incidence and types of wound-related complications in the 12 weeks following surgery.
Participants will give informed consent before surgery and will start the study once the dressing has been applied following surgery. There will be follow up study visits at discharge, 7 days, 12 days, 6 weeks and 12 weeks post-surgery. Data relating to vital signs, medical history, surgery and medication will be taken from routine data.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (18+) undergoing primary total hip or knee replacement
Enrolled in an ERAS protocol
Willing and able to provide informed consent
Disqualifiers
Requiring revision replacement
Unable to provide informed consent (cognitive disorder such as dementia, psychiatric illness)
Unable to understand written English
Trial population
Patients undergoing primary total hip or knee replacement at the Nuffield Health Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Wound Dressing Material
Other interventionThe study will investigate any wound dressing applied as part of routine care. Advanced wound dressings are highly absorbent, flexible and comfortable for surgical wounds, and offer up to 14 days wear time. The adhesive moulds to the skin without sticking to the wound, thus protecting the skin and wound from damage. They support patient mobilisation by being comfortable, and thereby minimising painful skin damage such as blisters.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The proportion of participants responding "yes" to each item of the ISWCAP checklist at 6-weeks post-surgery
Time frame
6-weeks post surgerySecondary outcomes
1
Incidence and types of wound complications such as infection, dehiscence (as measured by the Sandy Grading System for surgical wound dehiscence classification), and blistering in the 12-weeks following surgery
Time frame
From surgery until the 12-week follow-up appointment2
Bluebelle Wound Healing Questionnaire, completed at Visits 5 (12-days post-surgery) and 6 (6-weeks post-surgery)
Time frame
12-days post-surgery and 6-weeks post-surgery3
Dressing Comfort and Usability Survey completed at Visits 4 (7-days post-surgery) and 5 (12-days post-surgery)
Time frame
7- and 12-days post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Bournemouth University
Lead sponsor
Nuffield Health Bournemouth
Collaborator
Source ClinicalTrials.gov