An interventional study of negative pressure wound therapy and standard dressing in Knee Arthropathy, Hip Arthropathy and Negative Pressure Wound Therapy, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's planned enrollment of 82 is above the median of 60 across 470 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
Both 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.
Device: negative pressure wound therapy
Both 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.
Other: standard dressing
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.
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.
Wound-related complications
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.
Time frame: 21 days after surgery
Patient Scale and Observer Scale (POSAS)
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.
Time frame: 21 days after surgery
Multi-category visual analogue scale
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"
Time frame: 21 days after surgery
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Chinese University of Hong Kong