- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471243
Dressing-related Experiences and Surgical Site Self-care in Hip and Knee Replacement: an Observational Cohort Study (DRESS-X)
Dressing-Related Experiences and Surgical Site Self-Care in Hip and Knee Replacement: an Observational Cohort Study (DRESS-X)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tikki Immins
- Phone Number: +441202 962727
- Email: timmins@bournemouth.ac.uk
Study Contact Backup
- Name: Chloe Bascombe
- Phone Number: +441202 961945
- Email: cbascombe@bournemouth.ac.uk
Study Locations
-
-
Dorset
-
Bournemouth, Dorset, United Kingdom, BH1 1RW
- Recruiting
- Nuffield Health Hospital Bournemouth
-
Contact:
- Robert Middleton
-
Principal Investigator:
- Robert Middleton
-
Bournemouth, Dorset, United Kingdom, BH8 8EB
- Not yet recruiting
- Bournemouth University
-
Contact:
- Thomas Wainwright
- Phone Number: +441202 961656
- Email: twainwright@bournemouth.ac.uk
-
Principal Investigator:
- Thomas Wainwright
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (18+) undergoing primary total hip or knee replacement
- Enrolled in an ERAS protocol
- Willing and able to provide informed consent
Exclusion Criteria:
- Requiring revision replacement
- Unable to provide informed consent (cognitive disorder such as dementia, psychiatric illness)
- Unable to understand written English
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The proportion of participants responding "yes" to each item of the ISWCAP checklist at 6-weeks post-surgery
Time Frame: 6-weeks post surgery
|
6-weeks post surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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 appointment
|
From surgery until the 12-week follow-up appointment
|
|
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-surgery
|
12-days post-surgery and 6-weeks post-surgery
|
|
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-surgery
|
7- and 12-days post-surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Wainwright, Bournemouth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORI/14918/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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