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Routine Use of Negative Pressure Wound Therapy THR TKR RCT

Not Applicable
Recruiting
Conditions
Knee Arthropathy
Negative Pressure Wound Therapy
Hip Arthropathy
Interventions
Device: negative pressure wound therapy
Other: standard dressing
Registration Number
NCT06181097
Lead Sponsor
Chinese University of Hong Kong
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
82
Inclusion Criteria
  • Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
negative pressure wound therapynegative pressure wound therapyBoth groups will have layered closure with 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and 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. For the NPWT group, 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. For the standard dressing group, the same PICO dressing will be applied, but without the suction.
standard dressingstandard dressingBoth groups will have layered closure with 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and 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. For the NPWT group, 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. For the standard dressing group, the same PICO dressing will be applied, but without the suction.
Primary Outcome Measures
NameTimeMethod
Wound-related complications21 days after surgery

Recurrence of wound exudate, surgical site infections, dressing-related issues, readmission to hospital and any further surgical interventions will be documented by the research personnel status at 21 days after the index operation.

Secondary Outcome Measures
NameTimeMethod
Multi-category visual analogue scale21 days after surgery

The multi-category visual analogue scale (VAS) is a photograph based scale derived from evaluating standardised digital photographs in four categories (pigmentation, vascularity, acceptability and patient comfort) plus contour. The individual scores are added to give a single overall score ranging from "excellent" to "poor"

Patient Scale and Observer Scale (POSAS)21 days after surgery

The POSAS has category boxes to core nominal parameters, for example colour of the scar. Each item of both scales have a 10-point score, with 10 indicating the worse imaginable scar or sensation and 1 corresponding to normal scar or skin (normal pigmentation, no itching, etc.). The total score of both scale is calculated by summing up the score of each of the six items and ranges from 6 to 60.

Trial Locations

Locations (1)

The Chinese University of Hong Kong

🇭🇰

Hong Kong, Hong Kong

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