Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05389410

Comparison of Surgical Wound Healing and Complications Following Revision Hip and Knee Replacements Using 7-day Versus 14-day Negative Pressure Wound Therapy Dressings

Led by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust · Updated on 2024-03-25

164

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of negative pressure wound therapy (NPWT) dressings in patients undergoing revision hip or revision knee surgery. This trial aims to compare wound healing and complications between two therapy durations: 7 days versus 14 days. The study focuses on whether one week of NPWT is sufficient or if two weeks provides better outcomes, especially considering wound healing through old scar tissue in revision surgeries. Participants will be randomly assigned to receive either a 7-day NPWT PICO dressing and pump (PICO 7) or a 14-day NPWT PICO dressing and pump (PICO 14). The 14-day group will have a dressing change at one week, with the pump paused during the change and restarted afterward. Both revision hip and revision knee surgery patients will be included, with equal numbers in each group. Throughout the study, researchers will assess wound fluid leakage by grading staining on the dressings at one and two weeks post-surgery. They will also monitor for wound breakdown, discharge, and infections up to six weeks after surgery. Photographs will document wound appearance from surgery through follow-up visits. Participants must attend scheduled outpatient visits and follow instructions for study participation.

CONDITIONS

Brief Title

PICO 7 vs PICO 14 in Revision Hip and Revision Knee Surgery.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
  • Participants must be able to follow instructions.
Not Eligible

You will not qualify if you...

  • Revisions for infection, where the infection significantly affects wound healing, discharge, or hospital stay.
  • Subjects with a history of poor compliance with medical treatment.
  • Subjects with contraindications or hypersensitivity to NPWT PICO dressing components such as silicone adhesives, polyurethane films, acrylic adhesives, polyethylene fabrics, or super-absorbent powders.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants must be able to make all required study visits to the Outpatients department.

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo revision hip or knee surgery followed by application of the negative pressure wound therapy (NPWT) dressing.

1 visit (surgery and dressing application)

Treatment

Duration - 7 or 14 days depending on randomization group

Participants receive NPWT using either a PICO 7 dressing for 7 days or a PICO 14 dressing for 14 days to promote wound healing after surgery.

1 to 2 visits depending on dressing change schedule

Post-operative Follow-up

Duration - Up to 6 weeks post-surgery

Participants are monitored for wound healing, complications, and wound appearance through follow-up visits.

Multiple outpatient visits over 6 weeks

Trial Site Locations

Total: 1 location

1

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, United Kingdom, SY10 7AG

Actively Recruiting

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Research Team

J

Julie Steen, BSc. (Hons)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Cost-effectiveness analysis of single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical site complications (SSC) in routine primary hip and knee replacements.

Leo M Nherera, Paul Trueman, Sudheer L Karlakki

https://pubmed.ncbi.nlm.nih.gov/28370637

NEGATIVE-PRESSURE WOUND THERAPY IN THE TREATMENT OF COMPLEX INJURIES AFTER TOTAL KNEE ARTHROPLASTY.

Camilo Partezani Helito, Daniel Kamura Bueno, Pedro Nogueira Giglio...

https://pubmed.ncbi.nlm.nih.gov/28642657

INCISIONAL NEGATIVE-PRESSURE WOUND THERAPY IN REVISION TOTAL HIP ARTHROPLASTY DUE TO INFECTION.

Helder de Souza Miyahara, Felipe Ribeiro Serzedello, Leandro Ejnisman...

https://pubmed.ncbi.nlm.nih.gov/30464709

Use of Closed Incisional Negative Pressure Wound Therapy After Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection: A Prospective, Randomized Clinical Trial.

Jared M Newman, Marcelo B P Siqueira, Alison K Klika...

https://pubmed.ncbi.nlm.nih.gov/30545653

Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: A randomised controlled trial.

S L Karlakki, A K Hamad, C Whittall...

https://pubmed.ncbi.nlm.nih.gov/27496913