Menu
Recruiting NCT06181097

Routine Use of Negative Pressure Wound Therapy THR TKR RCT

No phase Interventional Knee Arthropathy Hip Arthropathy Negative Pressure Wound Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: negative pressure wound therapy, standard dressing.
Who it may be relevant to
Registry conditions: Knee Arthropathy, Hip Arthropathy, Negative Pressure Wound Therapy. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Routine Use of Negative Pressure Wound Therapy in Primary Hip and Knee Arthroplasties; a Randomized Controlled Trial

Overview

Negative pressure wound therapy (NPWT) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. A prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. The number of wound complications within 21 days will be recorded. As well, the aesthetic appearance and quality of scarring of the scar will be assessed.

Interventions

  • Device negative pressure wound therapy
    The intervention group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility.
  • Other standard dressing
    The standard dressing group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The same PICO dressing will be applied, but without the suction.

Primary outcome measures

  • Wound-related complications [Time frame: 21 days after surgery]
Secondary outcome measures (2)
  • Patient Scale and Observer Scale (POSAS) [Time frame: 21 days after surgery]
  • Multi-category visual analogue scale [Time frame: 21 days after surgery]

Eligibility criteria

Inclusion criteria

  • Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong.

Exclusion criteria

  • Patients using steroid, or other immune modulators that is known to affect wound healing, prior surgery to the knee or hip, skin condition such as eczema that would result in poor healing or widen scars, patients with a known significant history of hypertrophic scarring or keloid.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT06181097 · 2023.208

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗