NCT07471243

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Apr 2026Aug 2027

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

Total Hip ReplacementTotal Knee Replacement

Keywords

Hip arthroplastyHip replacementKnee arthroplastyKnee replacementMusculoskeletalEnhanced recovery after surgeryERASSurgical wound

Outcome Measures

Primary Outcomes (1)

  • The proportion of participants responding "yes" to each item of the ISWCAP checklist at 6-weeks post-surgery

    6-weeks post surgery

Secondary Outcomes (3)

  • 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

    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)

    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)

    7- and 12-days post-surgery

Interventions

Wound Dressing MaterialOTHER

The 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing primary total hip or knee replacement at the Nuffield Health Hospital

You may qualify if:

  • Adults (18+) undergoing primary total hip or knee replacement
  • Enrolled in an ERAS protocol
  • Willing and able to provide informed consent

You may not qualify if:

  • Requiring revision replacement
  • Unable to provide informed consent (cognitive disorder such as dementia, psychiatric illness)
  • Unable to understand written English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nuffield Health Hospital Bournemouth

Bournemouth, Dorset, BH1 1RW, United Kingdom

Location

Bournemouth University

Bournemouth, Dorset, BH8 8EB, United Kingdom

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

Bandages

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Thomas Wainwright

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tikki Immins

CONTACT

+441202 962727timmins@bournemouth.ac.uk

Chloe Bascombe

CONTACT

+441202 961945cbascombe@bournemouth.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopaedics

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)