Comparing 7-day and 14-day wound dressings for revision hip and knee surgeries
Comparison of Surgical Wound Healing and Complications Following Revision Hip and Knee Replacements, Utilising a 7-day Versus 14-day Negative Pressure Wound Therapy (NPWT) Dressing. A Randomised Controlled Trial.
This study is testing whether using a wound dressing for 7 days or 14 days helps people heal better after hip and knee revision surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust Government |
| Locations | 1 site (Oswestry, Shropshire) |
| Trial ID | NCT05389410 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two different durations of negative pressure wound therapy (NPWT) dressings in patients undergoing revision hip and knee surgeries. Eligible participants will be randomly assigned to receive either a 7-day or a 14-day NPWT dressing treatment. The study will include a total of 164 patients, with 82 in each surgical cohort, to evaluate which duration is more effective in promoting wound healing. The trial is conducted at a single site, ensuring close monitoring and follow-up of all participants.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old requiring aseptic revision hip or knee surgery.
Not a fit: Patients with infections or contraindications to NPWT dressings will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize wound healing protocols, potentially reducing complications and improving recovery times for patients undergoing revision surgeries.
How similar studies have performed: Previous studies have shown benefits of NPWT in wound healing, but this specific comparison of treatment durations is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be over the age of 18 years. * Participants undergoing aseptic revision hip or aseptic revision knee surgery procedure (a single stage revision procedure). * Participants must be willing and be able to make all the required study visits to be seen by the research team at the Outpatients department at RJAH. * Participants must be able to follow instructions. Exclusion Criteria: * Revisions for infection, where the nature of the infection has a significant influence on the wound healing, discharge, and length of stay. * Subjects with a history of poor compliance with medical treatment. * Subjects with contraindications (as per the PICO Instructions for use) or hypersensitivity to the use of the NPWT PICO dressing product or its components e.g.: silicone adhesives, polyurethane films, acrylic adhesives, polyethylene fabrics and super- absorbent powders (polyacrylates) contained within the dressing.
Where this trial is running
Oswestry, Shropshire
- Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust — Oswestry, Shropshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sudheer L Karlakki — The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust
- Study coordinator: Julie Steen, BSc. (Hons)
- Email: julie.steen@nhs.net
- Phone: 01691404210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.