- 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
- Nuffield Health Hospital Bournemouth
-
Contact:
- Robert Middleton
-
Principal Investigator:
- Robert Middleton
-
Bournemouth, Dorset, United Kingdom, BH8 8EB
- 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 (Estimated)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Total Hip Replacement
-
Concentra AI, incRecruitingTotal Hip Replacement | Total Knee ReplacementUnited States
-
Ottawa Hospital Research InstituteThe Ottawa Hospital Academic Medical AssociationCompletedTotal Hip Replacement | Total Knee ReplacementCanada
-
The Royal Bournemouth HospitalCompletedArthroplasty, Replacement, Hip | Hip Replacement, TotalUnited Kingdom
-
Ortho Development CorporationOregon Health and Science UniversityEnrolling by invitationTotal Hip Replacement | Total Hip ArthroplastyUnited States
-
National Taiwan University HospitalUnknownTotal Hip Replacement | Total Hip ArthroplastyTaiwan
-
Mayo ClinicCompletedKnee Total Joint Replacement | Hip Total Joint ReplacementUnited States
-
ElsanNot yet recruitingPrimary Total Hip Arthroplasty | Primary Total Hip ReplacementFrance
-
Musgrave Park HospitalBelfast Health and Social Care Trust; Queen's University, Belfast; Belfast Arthroplasty...CompletedTotal Hip Replacement | Total Hip Arthroplasty | THA | THRUnited Kingdom
-
Symbios Orthopedie SARecruitingTotal Hip ReplacementFrance
-
University Hospitals Coventry and Warwickshire...Completed
Clinical Trials on Wound Dressing Material
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnGlioma | Ependymoma | Medulloblastoma | Pineoblastoma | Central Nervous System Sarcoma | Primary Central Nervous System Neoplasm | Malignant Intracranial Germ Cell TumorUnited States
-
LifeNet HealthRecruitingLower Extremity | Diabetic Foot Ulcer (DFU)United States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingBreast Carcinoma | Mastectomy PatientUnited States
-
The University of Texas Health Science Center,...CompletedPain From Free Gingival GraftUnited States
-
UPM BiomedicalsUniversity of HelsinkiCompleted
-
Princess Margaret Hospital, Hong KongUnknownSurgical Site InfectionHong Kong
-
University of MiamiCompleted
-
ETS Wound Care, LLCProfessional Education and Research InstituteCompletedDiabetic Foot | Diabetic Foot Ulcer | Ulcer FootUnited States
-
Vomaris InnovationsCompletedBurns | Wound HealingUnited States
-
Molnlycke Health Care ABEuraxi PharmaNot yet recruitingCompression Bandages | Venous Leg Ulcer (VLU)France